MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 8" (20 CM); CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CS-24301-E
Medical Device Problem Codes	Material Twisted/Bent (2981); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "on (b)(6) 2024,the swg is soft, it cannot be used together with the dilator when used on the patient.No harm for the patient." additional information reports "the swg is easy to kink." the user changed to a new set.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one opened cvc kit for analysis.No definite signs of use were observed.The reported guide wire was not returned for analysis.No defects or anomalies were observed with the other returned components.A device history record review was performed and no relevant findings were identified.The customer report of a kinked guide wire could not be confirmed through investigation of the returned sample.The guide wire was not returned; therefore, relevant inspections could not be performed.A device history record review revealed no relevant findings.Based on the customer report and without the guide wire returned for analysis, the potential root cause cannot be confirmed at this time.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported "on (b)(6) 2024,the swg is soft, it cannot be used together with the dilator when used on the patient.No harm for the patient." additional information reports "the swg is easy to kink." the user changed to a new set.There was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 16 GA X 8" (20 CM)
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 20322202
• Report Number: 3006425876-2024-00986
• Device Sequence Number: 12708459
• Product Code: FOZ
• UDI-Device Identifier: 00801902102225
• UDI-Public: (01)00801902102225(11)231201(17)251018(10)71F23L1401(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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 Expiration Date: 10/18/2025
• Device Catalogue Number: CS-24301-E
• Device Lot Number: 71F23L1401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown