C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 1806060J |
Device Problems
Component Misassembled (4004); Illegible Information (4050); Unclear Information (4052)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/25/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a port placement procedure, the physician noticed a problem with the lock connector.It was further reported that the problem was that the black line was not only on one residual limb, but also on the opposite limb, making it impossible to determine the correct connection.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 powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products are identified in d2 and g4.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 physician noticed a problem with the lock connector.It was further reported that the problem was that the black line was not only on one residual limb, but was also on the opposite limb, making it impossible to determine the correct connection.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 powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products that are cleared in the us.The pro code and 510 k number for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, 6f products are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one cath-lock was received for evaluation.Visual and dimensional evaluation was performed.The sample appeared to be clean.No other anomalies were noted.Manufacturing site evaluation of the sample found that the print at the opposite end was a black shadow caused by the reflection of the print.According to the review of the images it is not confirmed that the print is at both ends, but the print reflected at the other end causing a kind of mirage (visual effect).Therefore, the investigation is unconfirmed for reported black line on both side of cath-lock issue.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.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: g3.H11: h6 (device, method, result, conclusion).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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