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Catalog Number SXX50 |
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 04/09/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
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Event Description
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It was reported that the sterile package was pierced by inside needle which has left a hole on the package.Changed another one to complete the surgery.There was no adverse patient consequences reported.
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Manufacturer Narrative
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Product complaint #: (b)(4).Additional evaluation summary: an unopened sample of product code sxx50, lot lg6957 was returned for analysis.The product code sxx50 is multi-strand and contains eight strands double armed per packet.During the visual inspection of the sample, the sterile barrier was compromised due to pin hole was observed on the copolymer and top of msda folder.The sample folder was opened, it was noted that the needle was orientated vertically in the package and this caused the hole on cavity.Based on the samples condition, the assignable cause suggest an incorrect needle park resulting in pinhole on package.
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Search Alerts/Recalls
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