C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG TIP; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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Model Number N/A |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354); Material Perforation (2205); Device Contamination with Body Fluid (2317)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/18/2020 |
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 redy0083 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (redy0083) have been reported from the same facility in the (b)(6).
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Event Description
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It was reported, "outpatient for parenteral nutrition.The patient reported an arm pain when flushing catheter.The blood was observed on the covering when patient arrived at the hospital.The catheter was functional, but the content leaked out during flushing.The catheter had to be pulled out and cannulated over the wire and it was observed that the catheter was perforated." on (b)(6) 2020-sharp instrument damage was found on the returned catheter.
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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 leaking catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 4fr s/l powerpicc catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel.The returned product sample was evaluated and three splits were observed between the 34cm and 35cm depth markings.Microscopic examination of the catheter splits confirmed they were typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: ¿ the fracture surfaces were reflective in nature and contained striated patterns.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.¿ sharply formed fracture edges ¿ planar shape to the fracture surfaces ¿ blood residue was seen on the sample which showed that the product had undergone at least some use.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.
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Event Description
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It was reported, "outpatient for parenteral nutrition.The patient reported an arm pain when flushing catheter.The blood was observed on the covering when patient arrived at the hospital.The catheter was functional, but the content leaked out during flushing.The catheter had to be pulled out and cannulated over the wire and it was observed that the catheter was perforated." 12/23/2020-sharp instrument damage was found on the returned catheter.
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