C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1616070 |
Device Problems
Suction Problem (2170); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2024 |
Event Type
malfunction
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Event Description
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It was reported that sometimes post a port placement, the catheter allegedly became blocked while administering the drug solution.It was further reported that the catheter had issues in aspiration.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
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Manufacturer Narrative
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H10: 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.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.
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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: one clearvue slim implantable port attached to a catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.The port was patent to both infusion and aspiration.Therefore, the investigation is inconclusive for the reported suction and obstruction issues as there were no difficulty in aspiration and infusion was identified during evaluation and the sample evaluation results indicating no difficulty under laboratory conditions are not by themselves sufficient to confirm that this event did not occur under clinical conditions.A definitive root cause could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.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.
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Event Description
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It was reported that sometimes post a port placement, the catheter allegedly became blocked while administering the drug solution.It was further reported that the catheter had issues in aspiration.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
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Search Alerts/Recalls
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