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Model Number BNBJ631002 |
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 08/24/2022 |
Event Type
malfunction
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Event Description
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According to the available information, the primary packaging was sealed over part of the catheter, with part of the loop coming out of the package, compromising product sterility.
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Manufacturer Narrative
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Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.
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Search Alerts/Recalls
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