MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number	IPN918726
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).Associated mdr#s 3006425876-2023-00762.
Event or Problem Description
It was reported that: "an incident occcured on (b)(6) 2023 in medical resuscitation of pneumology department.There was a rupture of the right wing of the juncture hub during suture fixation." there was no catheter migration.It was reported there was no paitent harm or consequence as when the device broke, another one was used.The wing of the second device broke also.The catheter was not removed and the user "attached it differently to solve the issue".
Additional Manufacturer Narrative
Qn#(b)(4).Upon additional review it was found that the malfunction reported by the customer was not reportable; thus the initial mdr, submitted on 08/10/2023, should be retracted.
Event or Problem Description
It was reported that: "an incident occcured on (b)(6) 2023 in medical resuscitation of pneumology department.There was a rupture of the right wing of the juncture hub during suture fixation." there was no catheter migration.It was reported there was no paitent harm or consequence as when the device broke, another one was used.The wing of the second device broke also.The catheter was not removed and the user "attached it differently to solve the issue".

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• 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: 17504147
• Report Number: 3006425876-2023-00763
• Device Sequence Number: 6796619
• Product Code: DQY
• UDI-Device Identifier: 10801902029239
• UDI-Public: 10801902029239
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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 Model Number: IPN918726
• Device Catalogue Number: CV-12854
• Device Lot Number: 71F22J3285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2022
• 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