Catalog Number 60-5181-103 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.
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Event Description
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During incoming inspection, the distributor rejected this device, 60-5181-103, for an insufficient heatseal.There was no contact with the patient as this was found during incoming inspection.Due to the potential severity of a breach in sterility, this complaint meets the criteria for a reportable event.This will be reported as a malfunction with potential for injury upon reoccurrence.
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Manufacturer Narrative
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Performed a visual inspection of the device, side of the packaging not sealed completely.Performed a functional inspection, the device was dye leak tested per tm-10-217 rev.F which indicated that the packaging did not have an insufficient heat seal.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution was found to have met all specifications prior to shipment.A lot history review shows that there have been no similar complaints on this part/lot combination over the past two years.(b)(4).Per the instructions for use, the user is advised the following: these devices should be inspected before and after each use.Visually examine the devices for obvious physical damage.This issue will continue to be monitored through the complaint system to assure patient safety.
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Search Alerts/Recalls
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