Catalog Number 306574 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported while using bd posiflush¿ pre-filled saline syringe three syringes were found to be broken before use.There was no report of patient impact.The following information was provided by the initial reporter: one of the last boxes/cartons of the delivered palette was damaged.The box/carton was still closed but had a big hole in it.The damage reaches into the box/carton into 3 packaging units of the product (some products don't even contain nacl anymore).
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Manufacturer Narrative
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A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported while using bd posiflush¿ pre-filled saline syringe three syringes were found to be broken before use.There was no report of patient impact.The following information was provided by the initial reporter: one of the last boxes/cartons of the delivered palette was damaged.The box/carton was still closed but had a big hole in it.The damage reaches into the box/carton into 3 packaging units of the product (some products don't even contain nacl anymore).
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Event Description
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It was reported while using bd posiflush¿ pre-filled saline syringe three syringes were found to be broken before use.There was no report of patient impact.The following information was provided by the initial reporter: one of the last boxes/cartons of the delivered palette was damaged.The box/carton was still closed but had a big hole in it.The damage reaches into the box/carton into 3 packaging units of the product (some products don't even contain nacl anymore).
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Manufacturer Narrative
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Correction: after further evaluation of the complaint, it has been determined that the previously submitted mfr report # was sent in error.This device issue was caused by shipping incidents, not a manufacturing issue.As the problem was not caused by bd, cancelation has been requested for this complaint.
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Search Alerts/Recalls
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