C.R. BARD, INC. (BASD) -3006260740 POWERPICC 4F NURSE BASIC TRAY WITH MICROINTRODUCER (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Infiltration into Tissue (1931)
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Event Date 06/27/2022 |
Event Type
malfunction
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Event Description
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It was reported that extravasation occurred at the insertion site when the catheter in this patient was being maintained.Due to the concern about potential problems in the future use, the customer removed the catheter.An examination showed that the catheter was severely damaged at the scale of 14.5cm.
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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 lot history review (lhr) of refw2427 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (refw2427) have been reported from facility china.
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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 a damaged catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which depicted a 4fr s/l powerpicc catheter.The depicted region included a segment of catheter shaft.A partially circumferential split was observed.Depth marking wear, curved shape memory, buckling and discoloration were observed in the vicinity of the split.The catheter features in the vicinity of the fracture suggested that cyclic kinking of the catheter contributed to the catheter damage; however, it could not be determined if an additional unidentified factor(s) also contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.H3 other text : evaluation findings are in section h.11.
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Event Description
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It was reported that extravasation occurred at the insertion site when the catheter in this patient was being maintained.Due to the concern about potential problems in the future use, the customer removed the catheter.An examination showed that the catheter was severely damaged at the scale of 14.5cm.
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Event Description
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It was reported that extravasation occurred at the insertion site when the catheter in this patient was being maintained.Due to the concern about potential problems in the future use, the customer removed the catheter.An examination showed that the catheter was severely damaged at the scale of 14.5cm.
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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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak was confirmed.The product returned for evaluation was one 4 fr single lumen powerpicc catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated, and a large split was observed approximately 15.5 cm distal to molded joint.The catheter split contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned fracture edges which were rounded and polished due to repeated material wear 'c' shaped impressions leading into the fracture site which are consistent with material buckling due to movement which caused the fracture edges to be pressed together overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing).An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.H3 other text : evaluation findings are in section h.11.
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Event Description
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It was reported that extravasation occurred at the insertion site when the catheter in this patient was being maintained.Due to the concern about potential problems in the future use, the customer removed the catheter.An examination showed that the catheter was severely damaged at the scale of 14.5cm.On (b)(6) 2023, defective product exhibited catheter discoloration problem.
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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.
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Event Description
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It was reported that extravasation occurred at the insertion site when the catheter in this patient was being maintained.Due to the concern about potential problems in the future use, the customer removed the catheter.An examination showed that the catheter was severely damaged at the scale of 14.5cm.On (b)(6) 2023, defective product exhibited catheter discoloration problem.
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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, complaint and lot history review, applicable previous investigation(s), sample analysis, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak was confirmed.The product returned for evaluation was one 4 fr single lumen powerpicc catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated, and a large split was observed approximately 15.5 cm distal to molded joint.The catheter split contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned; fracture edges which were rounded and polished due to repeated material wear; 'c' shaped impressions leading into the fracture site which are consistent with material buckling due to movement which caused the fracture edges to be pressed together; overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing).Some discoloration was observed on a portion of the catheter tubing and the extension leg; this discoloration may have been caused by dressing and/or cleaning materials used to maintain the catheter.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.H3 other text: evaluation findings are in section h11.
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