MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 14 GA X 6IN (16 CM); CATHETER PERCUTANEOUS

Model Number	IPN929034
Medical Device Problem Codes	Crack (1135); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during initial insertion into the right internal jugular (rij) vein, aspiration was performed; however, the attached syringe drew only air.This observation prompted further evaluation, which led to identification of a potential device issue.Upon closer inspection, the plastic hub (needle cone) was found to contain multiple hairline cracks that had not been apparent during the initial visual inspection.A subsequent puncture was performed using a needle from a three-lumen central venous catheter set, and the procedure was completed successfully.There were no reports of patient complications associated with this event.No additional medical intervention was required beyond removal of the initial puncture needle and a second puncture to the rij vein.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ARROW CVC SET: 14 GA X 6IN (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: 25178658
• Report Number: 3006425876-2026-00521
• Device Sequence Number: 18814783
• Product Code: DQY
• UDI-Device Identifier: 10801902184969
• UDI-Public: (01)10801902184969(11)250804(17)300731(10)71F25G0327(21)
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K862056
• 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): 04/21/2026

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: IPN929034
• Device Catalogue Number: ES-04706
• Device Lot Number: 71F25G0327
• 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: 04/21/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/14/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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.
• Patient Age: 82 YR
• Patient Sex: Unknown