C.R. BARD, INC. (BASD) -3006260740 ACCUCATH, ACE 20GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refs1506 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported "accucath ace wire knotted up during insertion, was difficult to remove from patient." no other information was provided.
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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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of accucath guidewire damage was confirmed.The product returned for evaluation was one 20ga x 2.25¿ accucath ace peripheral iv catheter assembly.Usage residues were observed throughout the sample.The catheter had been advanced and was not returned for evaluation.The safety button was depressed and the needle was fully withdrawn in to the housing.The guidewire exhibited deformation within the coil region.The wire appeared to be intact.Microscopic inspection of the guidewire confirmed it to be intact.A sharp kink was observed within the coil region, leading to misaligned coils.Blood residue was evident on the guidewire and the needle.The guidewire deformation was consistent with damage caused by attempted advancement against resistance, such as into tissue.The use residues suggested that advancement against resistance occurred during device use.H3 other text: evaluation findings are in section h11.
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Event Description
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It was reported "accucath ace wire knotted up during insertion, was difficult to remove from patient." no other information was provided.
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Search Alerts/Recalls
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