C.R. BARD, INC. (BASD) -3006260740 BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM)
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Model Number N/A |
Device Problem
Material Deformation (2976)
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Patient Problem
Pain (1994)
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Event Date 02/08/2024 |
Event Type
malfunction
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Event Description
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It was reported that during the installation of this device, the metal guide became stuck in the bevel of the needle, making it impossible to remove.Faced with this situation, the medical staff had to remove the needle and guide, and then open a second device to complete the procedure.
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Manufacturer Narrative
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H11: the information provided by bd represents all of 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.The manufacturer has received the sample and will evaluate.Results are expected soon.
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Manufacturer Narrative
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H11: section a through f - the information provided by bd represents all of 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.The complaint of the inability to advance the guidewire through the introducer needle is confirmed and was determined to be use related.The products returned for evaluation were a 21ga introducer needle and two nitinol guidewires.Use residue was observed on the introducer needle and both guidewires.One of the guidewires was returned in a plastic hoop.The other guidewire was partially advanced through the introducer needle and the distal end of the guidewire was protruding out of the needle.The guidewire exhibited some resistance as it was removed from the introducer needle by gently advancing it all the way through the needle.A non-complainant nitinol guidewire was advance through the introducer needle successfully with a little resistance, likely due to use residue adhered to the needle shaft.Microscopic inspection of the guidewires revealed both were intact.The guidewire that was removed from the introducer needle exhibited misaligned coils near the distal end.Microscopic inspection of the needle bevel revealed some deformation.The misaligned coils on the distal end of the guidewire and deformation on the needle bevel suggests the guidewire was advanced against resistance and likely withdrawn against the needle bevel.Additionally, the amount of use residue on and around the samples may have contributed to difficulty manipulating the guidewire.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h11.
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Event Description
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It was reported that during the installation of this device, the metal guide became stuck in the bevel of the needle, making it impossible to remove.Faced with this situation, the medical staff had to remove the needle and guide, and then open a second device to complete the procedure.
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