MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM; CATHETER HEMODIALYSIS NON IMPL

Catalog Number	CS-12142-F
Medical Device Problem Codes	Unraveled Material (1664); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the wire is too thick for the ars and it sometimes meets with resistance before the wire even exits the tip of needle".Additional information reports, the guidewire got in the stuck syringe once the wire unravelled.The device was removed.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) udi number unavailable as complainant did not report a lot number.The customer provided two photos for analysis.The photos show a separated guide wire and a damaged ars.This complaint was created to address the report of an unraveled guide wire.Based on the appearance of the damage in the photos, the event involving the unraveled guide wire was not pictured.Without the device pictured or the device returned for evaluation, complete visual inspection could not be performed, and the potential root cause could not be determined.The customer report of an unraveled guide wire was not confirmed by visual inspection of the customer supplied photos.Full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.Without the device to evaluate, 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 "the wire is too thick for the ars and it sometimes meets with resistance before the wire even exits the tip of needle".Additional information reports, the guidewire got in the stuck syringe once the wire unravelled.The device was removed.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 15 CM
• Common Device Name: CATHETER HEMODIALYSIS NON IMPL
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19497683
• Report Number: 3006425876-2024-00590
• Device Sequence Number: 6661149
• Product Code: MPB
• UDI-Device Identifier: 00801902100122
• UDI-Public: 00801902100122
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K991431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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-12142-F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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