C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
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Catalog Number 9808560 |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/25/2024 |
Event Type
malfunction
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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 return of the sample is pending.The investigation of the reported event is currently underway.H11: 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 one month and twenty days post a port placement, a small amount of leakage was allegedly found when the water was injected into the removed port.It was further reported that there were allegedly two damaged areas of the same length noted in the opposite directions of the device.Furthermore, the patient experienced pain and redness, however there is no information on any intervention or medications provided for treatment.There was no reported patient injury.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one powerport mri isp implantable port attached to a groshong catheter was returned for evaluation.Functional, gross visual, tactile and microscopic visual evaluations were performed.The pinholes were noted on the attached catheter.Upon infusion, a leak was observed from the pinholes on the attached catheter.Therefore the investigation is confirmed for the reported leak and identified material puncture/hole issue.However the investigation is unconfirmed for the reported material integrity issue as the more specific damage such as pinhole was identified during the investigation.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.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 one month and twenty days post a port placement, a small amount of leakage was allegedly found when the water was injected into the removed port.It was further reported that there were allegedly two damaged areas of the same length noted in the opposite directions of the device.Furthermore, the patient experienced pain and redness, however there is no information on any intervention or medications provided for treatment.There was no reported patient injury.
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Search Alerts/Recalls
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