C.R. BARD, INC. (BASD) -3006260740 POWER PORT ISP M.R.I., 8FR GROSHONG; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 4808570J |
Device Problems
Difficult to Insert (1316); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/05/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a port placement procedure below the clavicle, the port was allegedly difficult to insert.It was further reported that the black sheath tip was allegedly deformed.There was no reported patient injury.
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Manufacturer Narrative
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H10: the catalog number identified in section d4: has not been cleared in the us but is similar to the power port isp m.R.I., 8fr groshong that are cleared in the us.The pro code and 510 k number for the power port isp m.R.I., 8fr groshong are identified in d2 and g4.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 below the clavicle, the port was allegedly difficult to insert.It was further reported that the black sheath tip was allegedly deformed.There was no reported patient injury.
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Manufacturer Narrative
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The catalog number identified in section d4 has not been cleared in the us but is similar to the power port isp m.R.I., 8fr groshong that are cleared in the us.The pro code and 510 k number for the power port isp m.R.I., 8fr groshong are identified in d2 and g4.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 8.0fr peel-apart sheath and vessel dilator were returned for evaluation.Gross visual and microscopic visual evaluations were performed.The peel-apart sheath and vessel dilator was noted to be bent.The distal tip of the peel-apart sheath was noted to be deformed.Therefore, the investigation is confirmed for the reported the black sheath tip was deformed and identified dilator bent.Also, the investigation is inconclusive for reported difficult to insert issue.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.(expiration date: 07/2025), 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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