MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number	CV-15703-E
Medical Device Problem Codes	Difficult to Advance (2920); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 "during the catheter insertion procedure, a problem was identified with the guide wire: difficulty in advancing the wire, bending of the guide, excessive resistance when trying to insert it.On the second attempt, the material from the same batch also had the same problem." the patient's current condition is reported as "unknown".Associated mdr numbers include: 3006425876-2024-01157.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20825203
• Report Number: 3006425876-2024-01155
• Device Sequence Number: 20796233
• Product Code: DQY
• UDI-Device Identifier: 00801902000606
• UDI-Public: (01)00801902000606(11)220712(17)270630(10)71F22G0977(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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: CV-15703-E
• Device Lot Number: 71F22G0977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• 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.
• Patient Sex: Unknown