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 0602680 |
Device Problems
Break (1069); Entrapment of Device (1212); Fracture (1260); Difficult to Remove (1528); Material Separation (1562); Stretched (1601); Unraveled Material (1664); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2023 |
Event Type
malfunction
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Event Description
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It was reported that during a port placement procedure, the guide wire allegedly broke.It was further reported that the guidewire allegedly got tangled with the dilator when it was removed.There was no reported patient injury.
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Manufacturer Narrative
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H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 guide wire was allegedly broke.It was further reported that it was tangled with the dilator when it was removed.The procedure was completed by using another device.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 bardport mri implantable port kit was returned for evaluation.Visual and microscopic evaluations were performed on the returned device.The flat core wire was noted to have a complete break on the proximal end.Both core wires were exposed on the uncoiled proximal portion of the guidewire.Therefore the investigation is confirmed for the reported fracture and the identified material separation, stretched and unraveled issues.However the investigation is inconclusive for the reported guidewire tangled with the dilator and difficulty in removing issues as no functional tests were performed due to the condition of the device.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: d4 (expiration date: 07/2026).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.
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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.The investigation of the reported event is currently underway.(expiration date: 07/2026), 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 guide wire was allegedly broke.It was further reported that it got tangled with the dilator when it was removed.The procedure was completed by using another device.There was no reported patient injury.
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Search Alerts/Recalls
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