MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15192-VFE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "(b)(6) 2024, the doctor found the pinch clamp broken during used on the patient." the patient was reported as fine.
Event or Problem Description
It was reported that: "(b)(6) 2024, the doctor found the pinch clamp broken during used on the patient." the patient was reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).Upon investigation of the returned sample, it was found that the malfunction was not reportable; thus the initial mdr, submitted on 24 may 2024, should be retracted.

• Brand Name: HEMODIALYSIS SET: 2-L 15 FR X 19 CM RETR
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• 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, NC 27560
• MDR Report Key: 19390245
• Report Number: 9680794-2024-00504
• Device Sequence Number: 6955611
• Product Code: MSD
• UDI-Device Identifier: 10801902127171
• UDI-Public: 10801902127171
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141051
• 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): 04/29/2024

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: 05/31/2026
• Device Catalogue Number: CS-15192-VFE
• Device Lot Number: 33F23E0776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2023
• 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