C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6CF INT W SP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8806060 |
Device Problems
Difficult to Flush (1251); Obstruction of Flow (2423); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4: (expiry date: 08/2023).H11: section a: through f: the information provided by bd represents all of 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 during a preparation of port placement procedure in the right internal jugular vein, the puncture needle was allegedly not smooth when flushing and a metal substance was allegedly found blocking inside the puncture needle.The procedure was completed using another device.There was no patient contact.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation, one electronic photo was provided for review.No visual anomalies were noted.Therefore, the investigation is inconclusive for the reported needle obstruction, difficult to flush and contamination issue as no objective evidence was obtained from the provided photo.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 08/2023), h6 (method).H11: h6 (result, conclusion).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 during a preparation of port placement procedure via the right internal jugular vein, the puncture needle was allegedly not smooth when flushing and a metal substance was allegedly found blocking inside the puncture needle.The procedure was completed using another device.There was no patient contact.
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Search Alerts/Recalls
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