C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 7707540J |
Device Problems
Fracture (1260); Dent in Material (2526)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/25/2023 |
Event Type
malfunction
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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 x-port isp implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f products 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: 05/2022).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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Event Description
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It was reported that five years, eight months, and nineteen days post port placement via the right subclavian vein, the catheter was allegedly found to be broken.There was no reported patient injury.
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Event Description
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It was reported that five years, eight months, and nineteen days post port placement via the right subclavian vein, the catheter was allegedly found to be broken.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 x-port isp implantable port, groshong single-lumen, 8f products that are cleared in the us.The pro code and 510 k number for the x-port isp implantable port, groshong single-lumen, 8f products are identified in d2 and g4.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 x-port implantable port attached to a groshong catheter was received for evaluation.Visual, microscopic, functional and tactile evaluations were performed.A complete circumferential break was noted on the distal end of the attached catheter that was elliptical in shape.The edges of the complete circumferential break on the distal end of the attached catheter were noted to be uneven.The surface was noted to be granular in one region and smooth in the other region.A small longitudinal split was noted on the border of both regions.Therefore, the investigation is confirmed for the reported fracture and the identified dent issues.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.H10: d4 (expiration date: 05/2022).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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