MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN918561
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when a catheter was inserted, the wings broke, at the moment of attaching it to the patient.A second catheter from the same lot number was used, and the same incident occurred.A third catheter from a different lot number was used successfully.The patient required three catheter insertions in a row, during which the local anaesthetic was no longer working, and causing loss of time.It was also observed that the wings are already "cut" in the packaging on all for the affected lot.The associated emdr report numbers are 3006425876-2025-00092, 3006425876-2025-00093 and 3006425876-2025-00094.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Upon further review of the complaint during investigation, it was determined that it was not a reportable event.Thus, the initial mdr submitted on 14th jan 2025 should be retracted.
Event or Problem Description
It was reported that when a catheter was inserted, the wings broke, at the moment of attaching it to the patient.A second catheter from the same lot number was used, and the same incident occurred.A third catheter from a different lot number was used successfully.The patient required three catheter insertions in a row, during which the local anaesthetic was no longer working, and causing loss of time.It was also observed that the wings are already "cut" in the packaging on all for the affected lot.The associated emdr report numbers are 3006425876-2025-00092, 3006425876-2025-00093 and 3006425876-2025-00094.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 20CM
• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21149349
• Report Number: 3006425876-2025-00094
• Device Sequence Number: 9262898
• Product Code: DQY
• UDI-Device Identifier: 10801902029291
• UDI-Public: (01)10801902029291(11)240606(17)281130(10)71F24E1312(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• 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): 12/24/2024

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 Model Number: IPN918561
• Device Catalogue Number: CV-15854
• Device Lot Number: 71F24E1312
• 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: 12/24/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2024
• 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