C.R. BARD, INC. (BASD) -3006260740 M.R.I. IMPLANTABLE PORT, HICKMAN SINGLE-LUMEN, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 0602690 |
Device Problems
Component Missing (2306); Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/04/2023 |
Event Type
malfunction
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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.The investigation of the reported event is currently underway.H10: d4 (expiration date: 05/2026).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 prior to a port placement procedure, when opening the product box, the catheter was allegedly found to be disassembled.It was further reported that the catheter size described in the product box was allegedly different than the catheter present inside.There was no patient contact.
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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: one powerport mri implantable port kit was returned for evaluation.Gross visual evaluation was performed.Components were compared against content list and the received hickman radiopaque silicone single-lumen catheter (6.6f/75cm) did match product list.However, the investigation is inconclusive for the reported component missing and component misassembled issues as the package was received unsealed.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: b5, d4 (expiration date: 05/2026), g3, h6 (device).H11: h6 (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.H3 other text : see h10.
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Event Description
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It was reported that prior to a port placement procedure, when opening the product box, the catheter was allegedly found to be misassembled.It was further reported that the catheter size described in the product box was allegedly different than the catheter present inside.The procedure was completed by using another device.There was no patient contact.
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Search Alerts/Recalls
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