Catalog Number 406091 |
Device Problems
Problem with Sterilization (1596); Packaging Problem (3007)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/07/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The pma/510(k)#: enforcement discretion.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd¿ epidural tray single shot, double deck tuohy 18 gauge 3-1/2 inch exhibited packaging failure and breach in sterility.No serious injury or medical intervention was reported.
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Manufacturer Narrative
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A sample was provided for evaluation.Evaluation of the sample confirmed the internal wrap was torn within the field of the wrap therefore failure mode is verified.The complaint sample evaluation was not able to identify a potential source for the tear.The probable root cause could not be identified.A review of the device history record shows that all inspection results passed per the dhr process and no anomalies were noticed during production.All anesthesia tray packaging are all 100% inspected throughout the process.Based on the evidence of the punctured wrap, which is highly visible, the defect would have triggered a rejection by the manufacturing personnel immediately.It is possible the tray caused the wrap to tear handling or during transportation post manufacturing.Consequently, the investigation was not able to identify a probable root cause.
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Event Description
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It was reported that bd epidural tray single shot, double deck tuohy 18 gauge 3-1/2 inch exhibited packaging failure and breach in sterility.No serious injury or medical intervention was reported.
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Search Alerts/Recalls
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