C.R. BARD, INC. (BASD) -3006260740 FULL KIT 20G X 10 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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Model Number N/A |
Device Problems
Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refr1295 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported "when doing powerglide training, during a bedside insertion, catheter was placed without difficultly (no resheathing of catheter or stress to device noted).After catheter was advanced attempted to aspirate blood return and air was noted entering the syringe.Insured that extension set was secure and properly attached.Again attempted to aspirate for blood return and air again noted entering the syringe, when flushing catheter was noted to be leaking where the catheter joins the hub.Catheter dc'ed intact with no injury to patient." add info rcvd 09/17/2021: what they¿re being treated for: rhabdomyolysis.
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Event Description
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It was reported "when doing powerglide training, during a bedside insertion, catheter was placed without difficultly (no resheathing of catheter or stress to device noted).After catheter was advanced attempted to aspirate blood return and air was noted entering the syringe.Insured that extension set was secure and properly attached.Again attempted to aspirate for blood return and air again noted entering the syringe, when flushing catheter was noted to be leaking where the catheter joins the hub.Catheter dc'ed intact with no injury to patient." add info rcvd 09/17/2021: what they¿re being treated for: rhabdomyolysis.
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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.The product returned for evaluation was one 20ga x 10cm powerglide pro catheter.Light usage residues were observed and the catheter exhibited curved shape memory.A v-shaped split was observed just distal of the molded joint between the luer adapter and catheter shaft.Microscopic inspection of the split revealed glossy, sharply defined fracture features.A regular, striated pattern was observed throughout the fracture surface.The fracture exhibited a tapered profile.The damage was consistent with contact between the catheter shaft and a sharp, pointed instrument such as a needle.Such damage can occur if the catheter is with drawn onto the introducer needle and/or if the needle is re-inserted following catheter advancement.This appeared consistent with the event description, which indicated that leakage was noted immediately following device placement.H3 other text : evaluation findings are in section h.11.
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Search Alerts/Recalls
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