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
Fracture (1260); Stretched (1601); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/06/2023 |
Event Type
malfunction
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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 isp kit was returned for evaluation.Gross visual, microscopic, dimensional and functional evaluations were performed.Upon visual evaluation the guidewire was noted be stretched distal to the j-hook and bends were also noted on the guidewire.A crack was noted to the introducer needle hub.During functional testing the guidewire felt stuck within the introducer needle when attempt to move the guidewire from the introducer needle.Therefore, the investigation is confirmed for the identified fracture, stretched, deformation due to compressive and physical resistance issues.The investigation in inconclusive for the reported failure to advance issue as the exact circumstances at the time of the reported event cannot be verified from the returned physical sample.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: 09/2024) 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 guidewire could not be allegedly advanced into the introducer needle.There was no reported patient injury.
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Search Alerts/Recalls
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