MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3L 7 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-12703-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was initially reported "the doctor found the swg tip kinked during use on the patient.They changed a new one.No harm for the patient." additional information clarified, "the catheter tip was damaged" instead.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was initially reported "the doctor found the swg tip kinked during use on the patient.They changed a new one.No harm for the patient." additional information clarified, "the catheter tip was damaged" instead.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Based on additional information received regarding the complaint description, it was determined that this event is not reportable; t herefore, the initial mdr submitted on 13-sep-2024 should be retracted.

• Brand Name: ARROW CVC SET: 3L 7 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20212195
• Report Number: 3006425876-2024-00911
• Device Sequence Number: 7801448
• Product Code: DQY
• UDI-Device Identifier: 00801902102133
• UDI-Public: (01)00801902102133(11)210909(17)260831(10)71F21J0672(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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-12703-E
• Device Lot Number: 71F21J0672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2021
• 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