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

Catalog Number	CS-15232-VFE
Medical Device Problem Codes	Material Too Rigid or Stiff (1544); Material Separation (1562); Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn # (b)(4).
Event or Problem Description
It was reported "during the insertion of the chronic dialysis catheter, a complication occurred during removal of the peel-away sheath.It required an inappropriate effort to separate peel-away sheath.Sheath was separated very slowly in small interval, not continuously.Both parts of the sheath were stiff and sharp.The catheter was not damaged." the device was removed and a second tray was used.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided three images showing a peel-away sheath and product information.Visual analysis revealed that the peel-away sheath was defective and torn incorrectly.The customer also returned one peel-away sheath for analysis.No definite signs of use were observed.Visual inspection of the sheath revealed that the sheath score lines of the extrusion were wavy/scalloped.The sheath extrusion was still molded onto both tabs.It was also observed that the sheath was split down the entire length of the extrusion.Microscopic examination confirmed the damage.The sheath was not split along the perforated edge.A device history record review was performed and relevant findings were identified.An event investigation form was created for material cs-15232-vfe with batches 33p23k0339 and 33p23k0340 within scope to address the peelaway sheath tears incorrectly defect.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 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.
Event or Problem Description
It was reported "during the insertion of the chronic dialysis catheter, a complication occurred during removal of the peel-away sheath.It required an inappropriate effort to separate peel-away sheath.Sheath was separated very slowly in small interval, not continuously.Both parts of the sheath were stiff and sharp.The catheter was not damaged." the device was removed and a second tray was used.There was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR
• 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: 20397588
• Report Number: 9680794-2024-00992
• Device Sequence Number: 6262131
• Product Code: MSD
• UDI-Device Identifier: 10801902127256
• UDI-Public: (01)10801902127256(11)231101(17)261031(10)33F23K0176(21)
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2024

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?: No
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 33F23K0176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown