C.R. BARD, INC. (BASD) -3006260740 APHERESIS PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number A710962 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2023 |
Event Type
malfunction
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Event Description
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It was reported that sometime post port placement, the patient allegedly experienced redness, swelling and a small skin tear.However, there is no information provided regarding additional intervention or medication to treat redness, swelling and a small skin tear.There was no reported patient injury.
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Manufacturer Narrative
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As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.Device pending return.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.Furthermore, clinical conditions cannot be replicated to confirm these failures.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
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Event Description
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It was reported that sometime post port placement, the patient allegedly experienced redness, swelling and a small skin tear.However, there is no information provided regarding additional intervention or medication to treat redness, swelling and a small skin tear.There was no reported patient injury.
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Search Alerts/Recalls
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