Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Per bd corrective and preventive action (capa) corporate procedure, the reported issue does not represent a single significant incident that would trigger a capa.
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It was reported that 10 unspecified bd connecta¿ stopcocks had loose caps, and 3 had caps that disconnected from the tubing during use.The following information was provided by the initial reporter: "it was reported via post market survey that the clinician encountered occurrences of the bd plug is loose on bd connecta¿ stopcock(s) (10), the bd plug inadvertently disconnects from bd connecta¿ stopcock port during use (3), and it was difficult to attach to the open port (2).".
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