MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH PKGD: WEDGE 5 FR 110CM; CATHETER, FLOW DIRECTED

Catalog Number	AI-07124
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "we used 3 each arrow 5f bwp catheters on a patient today because two ofthem drew back air when the dr tried to pull back blood; one appears to have a hole in it and the other a crack---on the hubs? there was no difficulty connecting it to the catheter nor disconnecting it from the catheter".No patient injury or consequence reported.The patient's current condition is "unknown".Please see associated mdr #: 3010532612-2025-00720, 3010532612-2025-00736.
Additional Manufacturer Narrative
(b)(4) upon further review, it was determined that this complaint was created in error, thus, the initial mdr submitted on 08/08/2025 should be retracted.
Event or Problem Description
It was reported "we used 3 each arrow 5f bwp catheters on a patient today because two ofthem drew back air when the dr tried to pull back blood; one appears to have a hole in it and the other a crack---on the hubs? there was no difficulty connecting it to the catheter nor disconnecting it from the catheter".No patient injury or consequence reported.The patient's current condition is "unknown".Please see associated mdr #: 3010532612-2025-00720 ,3010532612-2025-00736, 3010532612-2025-00735.

• Brand Name: ARROW CATH PKGD: WEDGE 5 FR 110CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 22749656
• Report Number: 3010532612-2025-00735
• Device Sequence Number: 8716095
• Product Code: DYG
• UDI-Device Identifier: 00801902002853
• UDI-Public: (01)00801902002853(11)250529(17)261031(10)16F25E0084(21)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: AI-07124
• Device Lot Number: 16F25E0084
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2025
• 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
• Patient Sex: Unknown