MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2; CATHETER INTRAVASCULAR THERAP

Model Number	IPN036438
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
Customer reported "the j wire on the guidewire looks as though it is about to fall off".The issue was detected prior to patient use.No patient involvement.
Event or Problem Description
Customer reported "the j wire on the guidewire looks as though it is about to fall off." the issue was detected prior to patient use.No patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer provided one image for analysis.Visual analysis revealed that the distal j-bend contained a kink.The customer returned one guidewire assembly and lidstock for analysis.The spring wire guide (swg) assembly cap was the only subcomponent missing from the assembly.No definite signs-of-use were observed.Visual analysis revealed that the guide wire was slightly kinked/bent adjacent to the distal weld.During normal assembly, the kink in the guide would have been located inside the guide wire cap, protecting it from damage.No damage was noted on the tube assembly.Both welds appeared spherical and fully formed.The kink on the guide wire measured 3mm from the distal weld.The guide wire total length measured 602mm, which is within the specification limits of 596mm-604mm per the guide wire graphic.The guide wire outer diameter measured.799mm, which is within the specification limits of.788mm-.826mm per the guide wire graphic.The returned guide wire was advanced through a lab inventory ars and 18 ga introducer needle to functionally test per ifu, "advance spring-wire guide into arrow raulerson syringe approximately 10 cm until it passes through syringe valves".The swg passed through both with minimal resistance.A manual tug test confirmed both welds were fully intact on the guide wire.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use if package has been previously opened or damaged." the report that the spring wire guide was found to be kinked prior to use was confirmed through visual examination of the returned sample.The returned guide wire had one kink in its body.The swg passed all relevant dimensional and functional inspection.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.During normal packaging, the portion of the guide wire that kinked would have been located inside the guide wire cap, protecting it from damage.Therefore, it cannot be confirmed when the guide wire was kinked.The root cause of this investigation is undetermined.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2
• Common Device Name: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11776942
• Report Number: 9680794-2021-00201
• Device Sequence Number: 19819981
• Product Code: FOZ
• UDI-Device Identifier: 10801902117189
• UDI-Public: 10801902117189
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 06/30/2022
• Device Model Number: IPN036438
• Device Catalogue Number: CDC-45703-P1A
• Device Lot Number: 13F20J0888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1