MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL; INTRODUCER, CATHETER

Catalog Number	CDC-29903-XCN1A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).N/a.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "stainless steel needle driver tip broke off.Clinician stated that it occurred after suturing was completed so a new kit was not needed to complete the securement.The needle was slipping during the procedure but clinician was able to complete the suturing without issue.The needle driver broke after the last pass".No patient harm or injury.The patient status is reported as "fine.
Event or Problem Description
It was reported that "stainless steel needle driver tip broke off.Clinician stated that it occurred after suturing was completed so a new kit was not needed to complete the securement.The needle was slipping during the procedure but clinician was able to complete the suturing without issue.The needle driver broke after the last pass".No patient harm or injury.The patient status is reported as "fine.
Additional Manufacturer Narrative
(b)(4).Upon investigation of the returned sample, it was found that the malfunction was not reportable; thus, the initial mdr, submitted on 19 nov 2025, should be retracted.Other remarks: n/a.Corrected data: n/a.

• Brand Name: ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 23596700
• Report Number: 9680794-2025-01025
• Device Sequence Number: 10314613
• Product Code: DYB
• UDI-Device Identifier: 10801902179323
• UDI-Public: (01)10801902179323(11)250325(17)261130(10)33F24M0135(21)
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K940079
• 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): 10/22/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: CDC-29903-XCN1A
• Device Lot Number: 33F24M0135
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2025
• 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: N/A.; N/A.
• Patient Sex: Unknown