MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15192-VFIE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "08 july 2024, the doctor found the swg kinked prior to the patient.Involved 1 pc.".
Additional Manufacturer Narrative
(b)(4).The customer provided three images for analysis.The first and third photos show kinking of the distal j-bend without the end cap present, indicating the customer handled the wire.The second photo shows the complaint details.The customer returned one opened hemodialysis kit with a guide wire assembly for analysis.The guide wire straightener tube and end cap were returned fully assembled.Visual analysis revealed that the guide wire distal end was partially looped around the end cap and kinked in the distal j-bend that as exposed out of the end cap.Upon full and proper assembly, the guide wire kink would be located within the end cap, protecting it during packaging, storage, and shipping.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were full and spherical.It was additionally noted that no obvious damage was present on the returned packaging.Based on the customer photo, it was revealed that the assembly was handled by the customer.Therefore, it cannot be confirmed if the guide wire was advanced out of the end cap or correctly assembled when provided to the customer.The kink on the guide wire measured 3mm from the distal weld.The guide wire total length measured 101cm, which is within the specification of the guide wire product drawing.The guide wire outer diameter (od) measure 0.0375", which is within the specification of the guide wire product drawing.A manual tug test confirmed both welds were intact.R & d and mfg were consulted as a part of this complaint investigation.R & d stated that it is possible for the kinking to occur during shipping if the cap fell off the assembly.Mfg additionally stated that the observed damage could be a result of an external and significant force applied that would cause the guide wire to advance beyond the end cap.They confirmed that it is possible for the damage to occur during the assembly process.Therefore, due to the possibility that this occurred during the assembly process, the mfg facility will further investigate this issue.A device history record review was performed, and a potentially relevant finding was identified.Non-conformance was initiated for material regarding an incorrect sealing process.Further review of the finding revealed that it was not relevant to the reported event.The guide wire product drawing was reviewed as part of this complaint investigation.The instructions for use (ifu) provided with this kit was reviewed as part of this complaint investigation.The report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was looped around the end cap and kinked in the portion of the guide wire that was exposed.Based on the customer photos, it was noted that the assembly was handled by the customer.Despite this, based on feedback from r & d and mfg, it is both possible for the kinking to have occurred during shipping or for the guide wire to advance beyond the end cap if a significant force is applied, which can occur during the assembly of the guide wire.These would contribute to the kinking of the wire.Based on the circumstances, the potential root cause cannot be determined as various factors could contribute to the defect.However, due to the possibility that the assembly process contributed to the damage, the mfg facility further reviewed the event via non-conformance.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "08 july 2024, the doctor found the swg kinked prior to the patient.Involved 1 pc.".

• Brand Name: HEMODIALYSIS SET: 2-L 15 FR X 19 CM ANTE
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19880425
• Report Number: 9680794-2024-00729
• Device Sequence Number: 7208191
• Product Code: MSD
• UDI-Device Identifier: 10801902127195
• UDI-Public: (01)10801902127195(11)230919(17)260831(10)33F23H0611(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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 Expiration Date: 08/31/2026
• Device Catalogue Number: CS-15192-VFIE
• Device Lot Number: 33F23H0611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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.
• Patient Sex: Unknown