C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 9808560 |
Device Problems
Difficult to Flush (1251); Suction Problem (2170); Blocked Connection (2888)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2024 |
Event Type
malfunction
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Event Description
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It was reported that sometime post a port placement procedure via internal jugular vein, the huber needle was inserted to check for reverse bleeding, but allegedly no blood was drawn.It was further reported that there were allegedly issues found during both infusion and aspiration.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 provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 09/2025) 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 pending return.
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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: one powerport mri isp implantable port and one right-angle non-coring needle was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed on the returned device.An in-house syringe was attached to the returned right-angle non-coring needle and the non-coring needle was inserted into the port septum.The port body was patent to both infusion and aspiration without issue.No leaks were observed throughout tests.Therefore, the investigation is unconfirmed for the reported flushing and suction issues.However, the investigation is inconclusive for the reported blocked connection issue as the reported event cannot be confirmed from the sample evaluation.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: 09/2025), g3.H11: b5, h6 (method, 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 sometime post a port placement via the internal jugular vein, the huber needle was inserted to check for reverse bleeding, but allegedly no blood can be withdrawn.It was further reported that both the injection and aspiration were allegedly not possible.There was no reported patient injury.
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Search Alerts/Recalls
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