C.R. BARD, INC. (BASD) -3006260740 ACCUCATH, ACE 18GX2.25; 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 01/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer has received the sample and is pending evaluation.Results are expected soon.A batch history review (bhr) review is not possible, as no manufacturing batch number has been provided by the complainant.
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Event Description
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It was reported by the customer, accucath catheter kinking, patient line did not last and had to be stuck again.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, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of kinked iv catheters was confirmed.The product returned for evaluation was two 18ga x 2.25¿ accucath peripheral iv catheters.Usage residues were observed throughout both samples.The first sample (sample 1) exhibited three sharp kinks occurring from just distal of the molded joint to approximately 2cm from the molded joint.The second sample (sample 2) exhibited one sharp kink approximately 2.5cm from the molded joint.Microscopic inspection of both samples confirmed the presence of sharp kinks in the catheter shafts.Inspection of the distal ends of the catheters revealed deformation of both tips.The edges of the catheter tips were curved inward and buckled.The catheter kinking and tip deformations were consistent with catheter damage caused by advancement against resistance, such as into tissue.The use residues suggested that resistance was encountered during device use.H3 other text : evaluation findings are in section h.11.
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Event Description
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It was reported by the customer, accucath catheter kinking, patient line did not last and had to be stuck again.No other information was provided.Two devices were returned for evaluation.This report addresses the first device.
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