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

Catalog Number	CS-15282-VSP
Medical Device Problem Codes	Material Separation (1562); Separation Failure (2547)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the sheath did not peel away as it should have." additional information has been requested from the customer.
Event or Problem Description
It was reported that: "the sheath did not peel away as it should have.".
Additional Manufacturer Narrative
(b)(4).The customer returned one sheath for investigation.Visual inspection of the sheath revealed that one tab became completely separated from the extrusion.The separated tab was not returned for analysis.It was additionally noted that the entire sheath extrusion was completely torn on one side.Microscopic examination confirmed the damage and revealed that the point of tearing was irregular and not along the intended score lines.A device history record review was performed, and relevant findings were identified.An event investigation form was initiated for material c-70013-003 with batches 33p23k0611 and 33p23k0609 regarding a peel-away sheath tears incorrectly failure.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 tab breaking off was confirmed by the complaint investigation of the returned sample.The returned sheath additionally 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.
Additional Manufacturer Narrative
(b)(4).Additional information was received indicating the issue was detected during use on a patient.It was also reported that the peel away sheath was removed in its entirety.The procedure was completed successfully and the condition of the patient was reported as "fine".Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed, and a finding was identified; however, it could not be determined if the finding was relevant as the actual device was not returned for investigation.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "the sheath did not peel away as it should have.".

• 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: 19826721
• Report Number: 9680794-2024-00712
• Device Sequence Number: 8679554
• Product Code: MSD
• UDI-Device Identifier: 00801902096388
• UDI-Public: (01)00801902096388(11)231130(17)261130(10)33F23K0174(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: CS-15282-VSP
• Device Lot Number: 33F23K0174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 10/24/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/22/2024; 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• 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.; NOT REPORTED.
• Patient Sex: Unknown