MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920513
Medical Device Problem Codes	Break (1069); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the sheath would not separate when trying to peel back.The blue plastic section at the top then detached from one side of the sheath.The remaining parts of the peel away sheath were removed intact.The user used artery forceps to grip the end of the sheath that had broken and managed to separtate them.No patient harm was reported.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the sheath would not separate when trying to peel back.The blue plastic section at the top then detached from one side of the sheath.The remaining parts of the peel away sheath were removed intact.The user used artery forceps to grip the end of the sheath that had broken and managed to separtate them.No patient harm was reported.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The customer report of a peel-away sheath tab broken in use was able to be confirmed by the photo.The customer returned one safe-sheath for evaluation.The dilator was not returned.Visual inspection of the sheath confirmed that one of the sheath tabs fully separated from the rest of the sheath body.A portion of the sheath extrusion was still molded onto the separated tab.The point of separation occurred at the distal end of the tab.Microscopic examination confirmed the damage and revealed that the point of separation was not uniform.It was also noted that the peel-away sheath was completely split down the score lines.The sheath was wavy and deformed at the locations of separation.Per the dilator sheath product drawing, the total length of dilator should measure 8.50" with the hub assembly measuring 2.15".This means that the length of the component from the tip of the dilator to the sheath hub should be 6.35".The length of dilator tip that extends past the sheath should measure 1.34" +/- 0.30"; therefore, the length of the sheath body should measure between 4.71-5.31".The length of the sheath body measured 5.125", which is within the specifications per product drawing.Functional testing could not be performed due to the damage to the returned sheath.A device history record review was performed, and the following findings were identified: for material c-70013-003, two non-conformances were initiated for 13p21j0812 with regards to a peel-away sheath tearing incorrectly.These findings are relevant to this investigation.The instructions for use (ifu) provided with this kit states "introduce catheter through hemostasis valve/sheath and advance to desired position.Sharply snap the tabs of valve housing in a plane perpendicular to the long axis of sheath to split valve and split sheath apart while withdrawing from vessel." the customer report of a sheath tearing incorrectly was confirmed by a complaint investigation of the returned sample.The returned sheath did not separate along the score lines as intended.Based on the sample returned and the fact that the sheath is a purchased component, this is likely a supplier issue.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16546970
• Report Number: 9680794-2023-00154
• Device Sequence Number: 17653051
• Product Code: MSD
• UDI-Device Identifier: 30801902195518
• UDI-Public: 30801902195518
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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
• Device Expiration Date: 04/30/2025
• Device Model Number: IPN920513
• Device Catalogue Number: CS-15282-VSP
• Device Lot Number: 13F22E0091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown