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 1808560 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/04/2023 |
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 is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiration date: 07/2025).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.
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Event Description
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It was reported that during a port placement procedure, the device allegedly had hole.It was further reported that the device allegedly had an external leakage.The procedure was completed using another device.There was no reported patient injury.
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Event Description
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It was reported that during a port placement procedure, the device allegedly had hole.It was further reported that the device allegedly had an external leakage.The procedure was completed using another device.There was no reported patient injury.
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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 sample was returned for evaluation.One powerport isp mri implantable port kit with following components: one powerport implantable port, one introducer needle, one cath-lock, one vessel dilator, one vein pick, one straight-angle non-coring needle, one right-angle non-coring needle, one j-tip guidewire loaded in a guidewire hoop, one tunneler and one groshong catheter loaded with catheter stylet and a cath-lock were provided for review.A split was noted approximately 1.7cm from the proximal end of the catheter.Upon infusion, a leak was observed exiting the split in the attached catheter.Aspiration was attempted and was unsuccessful.Therefore, the investigation is confirmed for the reported fluid leak and the identified fracture issues.However, the investigation is unconfirmed for the reported material hole issue as no objective evidence of the catheter hole was noted and only splits were noted.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: 07/2025).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.
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Search Alerts/Recalls
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