Catalog Number 302832 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/22/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that holes were found in the bd luer-lok¿ tip syringe packaging before use, which compromised the product's sterility.The following information was provided by the initial reporter: "received 1 box of item and about 1/2 the box has holes in the packaging compromising the sterility of the item.".
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Event Description
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It was reported that holes were found in the bd luer-lok¿ tip syringe packaging before use, which compromised the product's sterility.The following information was provided by the initial reporter: "received 1 box of item and about 1/2 the box has holes in the packaging compromising the sterility of the item.".
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Manufacturer Narrative
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Investigation: no samples or photos were provided by the customer for investigation.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr review did not reveal any defects or issues reported and no quality notifications were issued.Based on the investigation conclusion and without a sample to analyze, the condition reported by the customer could not be confirmed nor could this symptom be correlated with a potential cause linked to the bd process.
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Search Alerts/Recalls
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