Catalog Number 382933 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.
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Event Description
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It was reported that bd iag bc pro global wing package seal integrity.The following information was provided by the initial reporter, translated from french to english: i am sending you a material safety report of zero clinical importance.We found 11 units of unsealed (primary packaging unsealed) and therefore non-sterile.We have not found this defect in other boxes from the same batch.We're not asking for credit or free units, i just wanted to let you know.
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Event Description
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No additional information.
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Manufacturer Narrative
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Investigation results: the complaint of unsealed packaging was confirmed and the cause appeared to be packaging related.Two photographs and eleven 20ga insyte autoguard units from lot #2340957 were provided for investigation.The eleven units did not exhibit a complete seal due to the top web being misaligned with the bottom web.This defect likely occurred during the packaging process.During the sealing process, it appeared that the top web was misaligned with the bottom web, which resulted in an incomplete and open seal.100% vision system and setup verification per procedures are in place to mitigate the occurrence of this defect.The appropriate manufacturing personnel were notified of this issue.
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Search Alerts/Recalls
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