MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15272-SFX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the wings of peal-away introducer valve body did not peeled away properly after catheter insertion." additional information received reports "the wings broke off correctly but i had to really force them to peel off the introducer." there was no patient consequences.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the wings of peal-away introducer valve body did not peeled away properly after catheter insertion." additional information received reports "the wings broke off correctly but i had to really force them to peel off the introducer." there was no patient consequences.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath and dilator for analysis.The sheath was returned advanced over the dilator.Definite signs of use were observed.Visual inspection of the sheath confirmed that it was torn incorrectly.The sheath extrusion was torn down the entire length of the extrusion along one side.Microscopic examination confirmed the damage and revealed that the point of tearing was irregular and not along the intended score lines.Despite this, the sheath extrusion was still molded to both tabs.Functional testing could not be performed due to the condition of the returned sample.A device history record review was performed and no relevant findings were identified.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.The sheath is manufactured by a third-party supplier.Therefore, based on the investigation performed, the supplier caused or contributed to this defect.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 27 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: 20824951
• Report Number: 9680794-2024-01168
• Device Sequence Number: 18105666
• Product Code: MSD
• UDI-Device Identifier: 00801902096340
• UDI-Public: (01)00801902096340(11)240213(17)270131(10)33F24A0280(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111900
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2024

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 Catalogue Number: CS-15272-SFX
• Device Lot Number: 33F24A0280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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