ARROW INTERNATIONAL LLC ARROW PI MIDLINE 1-L: 4FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC
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Model Number IPN056907 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/19/2023 |
Event Type
malfunction
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Event Description
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Customer complaint is reported as: "during the insertion of a midline, we noticed that the peel-away dilator is breaking little by little without having to force during peeling.The un-peeled end of the severed side of the dilator was then no longer visible, only the other peelable part, which allowed us to recover the entire device." the clinical consequence for the patient was a "need of additional care and unscheduled examination" as it took more time than scheduled to recover all the parts of the dilator."all the parts of the peel-away dilator were recovered with an applier.There was no part left visible under ultrasound, nor under control x-ray face and profile.".
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Manufacturer Narrative
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(b)(4).
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Event Description
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Customer complaint is reported as: "during the insertion of a midline, we noticed that the peel-away dilator is breaking little by little without having to force during peeling.The un-peeled end of the severed side of the dilator was then no longer visible, only the other peelable part, which allowed us to recover the entire device." the clinical consequence for the patient was a "need of additional care and unscheduled examination" as it took more time than scheduled to recover all the parts of the dilator."all the parts of the peel-away dilator were recovered with an applier.There was no part left visible under ultrasound, nor under control x-ray face and profile.".
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Manufacturer Narrative
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Qn#(b)(4).The customer returned one peel-away catheter for analysis.No definite signs of use were observed on the sheath.Visual analysis revealed that one of the peel-away sheath tabs was separated from the extrusion.A portion of the sheath body remained within the hub.The separation points appeared stretched and jagged.Microscopic examination revealed that the sheath did not fully tear along the score lines.One of the blue score lines was partially separated/torn.The peel-away sheath body length measured 2 3/4", which is within the specification limits of 2 5/8"-2 7/8" per product drawing.The peel-away sheath outer and inner diameters could not be accurately measured due to the condition of the returned sample.Functional testing could not be performed due to the condition of the returned sample.A manual tug test confirmed that the remaining tab was fully secured to the sheath body.A device history record review was performed, and no relevant findings were identified.The report of a peel-away sheath tearing incorrectly was confirmed through complaint investigation.Visual examination revealed one sheath tab was separated from the sheath extrusion.The sheath met all relevant dimensional requirements.The appearance of the defect is consistent with damage due to a manufacturing process.Based on the customer report and the sample received, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
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