C.R. BARD, INC. (BASD) -3006260740 UNIVERSAL MICROINTRODUCER KIT PTFE PEEL-APART SHEATH INTRO 4.5F X 5CM; INTRODUCER, CATHETER
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Model Number N/A |
Device Problem
Material Frayed (1262)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/05/2022 |
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 refs1550 showed one other similar product complaint(s) from this lot number.
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Event Description
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It was reported that patient was admitted to the due to the need for chemotherapy.After communication with the family of this patient, placement of the picc was conducted on (b)(6) 2022.During placement, the first insertion of guide wire in accessories of seldinger into the blood vessel failed.During the second attempt, serious bifurcation occurred.After communication with the head nurse, a product complaint needs to be filed.
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Event Description
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It was reported that patient was admitted to the due to the need for chemotherapy.After communication with the family of this patient, placement of the picc was conducted on april 5, 2022.During placement, the first insertion of guide wire in accessories of seldinger into the blood vessel failed.During the second attempt, serious bifurcation occurred.After communication with the head nurse, a product complaint needs to be filed.
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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 a damaged guidewire was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which appeared to depict a straight guidewire.The depicted region of the guidewire included the distal region.A sharp bend was evident in the coil wire.The core wire appeared to protrude from the bent region of the coil wire.Wire damage appeared evident in the submitted photograph; however, inspection of the photograph was insufficient to identify the cause of the damage.Potential contributing factors include retraction of the wire against the needle bevel and tensile (pulling) damage.
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Search Alerts/Recalls
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