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Catalog Number EZ10G |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Investigation summary: it was reported performance damaged product.An empty opened foil, a opened folder, a cannula and a pds suture in several pieces were returned for analysis.During the visual inspection of several suture pieces have begun with the process of degradation.Also, the foil was examined for visual inspection and showed multiples wrinkles and holes in cavity on bottom foil package due to excessive manipulation.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, the assignable cause of performance damaged product, was caused by suture degradation due to pin holes in cavity.
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Event Description
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It was reported that a patient underwent a cholecystectomy on (b)(6) 2018, and suture was used.During the procedure, the doctor was using the device for a cystic duct.The nurse went to remove the device from the packaging in order to use it in the operation.However, the product appeared to be brittle and broken prior to use with patient.There were no adverse patient consequences reported.Upon evaluation of the device, visual inspection of several suture pieces have begun with the process of degradation.Also, the foil was examined for visual inspection and showed multiples wrinkles and holes in cavity on bottom foil package due to excessive manipulation.No additional information was provided.
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Search Alerts/Recalls
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