MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 2-LUMEN 4 FR X 8 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15402-E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "(b)(6) 2024, the catheter tip was found deformed during use on the patient.The patient was reproted as fine.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
Qn# (b)(4)."new information received indicates that this was not a reportable event, thus, the initial mdr submitted on 13/05/2024 should be re tracted.".
Event or Problem Description
It was reported that: "(b)(6) 2024, the catheter tip was found deformed during use on the patient.The patient was reproted as fine.

• Brand Name: CVC SET: 2-LUMEN 4 FR X 8 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19298602
• Report Number: 3006425876-2024-00460
• Device Sequence Number: 6883298
• Product Code: DQY
• UDI-Device Identifier: 10801902099645
• UDI-Public: 10801902099645
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2024

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
• Device Catalogue Number: CS-15402-E
• Device Lot Number: 71F23H0257
• 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: 04/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2023
• 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