MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-24402
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during the procedure according to ifu, the md found the guide wire to be bent.So the md opened up the new kit to finish the procedure." there was no reported patient harm or consequence.They were reported as fine.
Event or Problem Description
It was reported that: "during the procedure according to ifu, the md found the guide wire to be bent.So the md opened up the new kit to finish the procedure." there was no reported patient harm or consequence.They were reported as fine.
Additional Manufacturer Narrative
(b)(4).The report that the guide wire kinked during use was confirmed through examination of the returned sample.The customer returned components from a cvc kit including one guide wire, a 21ga introducer needle, and a 2-lumen catheter for analysis.No obvious signs of use were observed on the guide wire.The guide wire was observed to have one kink on the distal j-bend and one kink towards the proximal end.The distal j-bend was misshapen but intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The returned guide wire met all relevant dimensional/functional requirements, and a device history record review based on sales history did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: CVC SET: 2-LUMEN 4 FR X 13 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19219421
• Report Number: 3006425876-2024-00408
• Device Sequence Number: 20893427
• Product Code: FOZ
• UDI-Device Identifier: 00801902102249
• UDI-Public: 00801902102249
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2024

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-24402
• Device Lot Number: UNKNOWN
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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