C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 8806061 |
Device Problems
Break (1069); Difficult to Remove (1528); Stretched (1601)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 02/20/2023 |
Event Type
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 is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway h10: d4 (expiry date: 02/2023).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 port placement procedure via the right internal jugular vein, resistance was allegedly felt when the guide wire was being removed.It was further reported that the tip of the guide wire was found to be drawn after removing the guidewire out of the vessel.The current status of the patient is unknown.
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Event Description
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It was reported that during a port placement procedure via the right internal jugular vein, resistance was allegedly felt when the guide wire was being removed.It was further reported that the tip of the guide wire was found to be drawn after removing the guidewire out of the vessel.The current status of the patient is stable.
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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 sample was not returned for evaluation and two electronic photos were provided for review.The investigation is confirmed for the reported guidewire stretched issue, as the coil wire of the guidewire was noted to be stretched from the provided photo.However, the investigation is inconclusive for the reported difficult to remove issue as the exact circumstances at the time of the reported event cannot be verified.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 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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Search Alerts/Recalls
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