C.R. BARD, INC. (BASD) -3006260740 X-PORT ISP IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Model Number 7707540 |
Device Problems
Difficult to Flush (1251); Fracture (1260); Material Separation (1562); Failure to Infuse (2340)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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, an image was provided for review.The investigation of the reported event is currently underway.(expiry date: 05/2023).
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Event Description
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It was reported that post port placement, the device allegedly failed to infuse.It was further reported that under x-ray, the catheter was broken near the neck of port.There was no reported patient injury.
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Event Description
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It was reported that post port placement, the device allegedly failed to infuse.It was further reported that under x-ray, the catheter was broken near the neck of port.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one x-port isp attached to a groshong catheter in two segments were returned for evaluation and one medical image was provided for review.Gross, microscopic visual and functional evaluations were performed.The investigation is inconclusive for the reported infusion problem as the exact circumstances at the time of reported event are unknown.However, the investigation is confirmed for the reported catheter fracture and the identified material separation issues, as a complete circumferential break was observed just distal to the cath-lock and the image review also confirms the same.Furthermore, the edges of the complete circumferential break were noted to be granular and smooth and two kinks were observed on the catheter approximately the 15cm depth mark and 9cm depth mark.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.H10: d4 (expiry date: 05/2023), g3 h11: h6 (device, method, result, conclusion) 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.H3 other text : see h10.
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Search Alerts/Recalls
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