When a hospital reports a missing component in a medical device kit, what should the manufacturer do?

When a hospital reports a missing component in a medical device kit, the manufacturer should initiate the manufacturer's Corrective and Preventive Action (CAPA) process. This action is crucial because the CAPA process is designed to address quality issues by investigating the root cause of the problem and implementing measures to prevent its recurrence.

Initiating a CAPA allows the manufacturer to thoroughly assess the situation, understand how the missing component impacts patient safety and product efficacy, and determine whether any other kits might be affected. This proactive approach also helps in documenting the findings and any corrective actions taken, which is vital for compliance with regulatory requirements and for maintaining quality assurance standards.

While notifying a Notified Body or a Competent Authority may be necessary in certain circumstances—especially if there is a potential risk to patient safety or a breach of regulations—the immediate priority should be to identify and resolve the issue at hand. The CAPA process provides a structured method for mitigating risks and improving product quality, making it an essential step following reports of this nature.