MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2L 5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14502
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the patient was admitted to the hospital for acute lymphocytic leukaemia and underwent central venous puncture treatment at 10:00 am on (b)(6) 20 24.Before using the central venous catheter package, doctor had checked the product (whether it was intact and damaged).At 10:30 am, the guide wire could not be inserted, and upon examination, it was found that there was a kinked problem with the guide wire.Then use the other end of the guide wire to advance.The patient was reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "the patient was admitted to the hospital for acute lymphocytic leukaemia and underwent central venous puncture treatment at 10:00 am on (b)(6) 2024.Before using the central venous catheter package, doctor had checked the product (whether it was intact and damaged).At 10:30 am, the guide wire could not be inserted, and upon examination, it was found that there was a kinked problem with the guide wire.Then use the other end of the guide wire to advance.The patient was reported as fine.

• Brand Name: ARROW CVC SET: 2L 5 FR X 13 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18928372
• Report Number: 3006425876-2024-00249
• Device Sequence Number: 11874565
• Product Code: DQY
• UDI-Device Identifier: 30801921122939
• UDI-Public: 30801921122939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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 Catalogue Number: CS-14502
• Device Lot Number: 71F22K1611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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