Catalog Number 391592 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that bd venflon catheter had foreign matter the following information was received by the initial reporter with the following verbatim: our sub stockiest purchased stock from our super stockiest nikesh ent, stock kept in their warehouse, at the time of stock verification identified that 3 items infested by pest inside the boxes only, outside carton is looking good and safe.
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Event Description
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Our sub stockiest purchased stock from our super stockiest nikesh ent, stock kept in their warehouse, at the time of stock verification identified that 3 items infested by pest inside the boxes only, outside carton is looking good and safe.
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Manufacturer Narrative
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03 photos were received by bd for evaluation.First photograph shows empty shelf packs in a pile on the floor.Second photograph shows a pile of unit pack in a pile inside a case carton.Third photograph shows a pile of unit packs with a brown color substance on one unit pack.The photograph does not confirm whether the brown substance is pest infestation, but it shows sign of foreign matter.The 25 retention samples were reviewed where the investigating team has visually inspected the samples for foreign matter and no such type of issue was found in the 25 retention samples.The exact root cause can only be determined if we receive the original sample.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.
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Search Alerts/Recalls
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