MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN918758
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: on (b)(6) 2024: after moving the patient, the nurse checked the lines and realized that the extension luer tip broke off and was stuck in the catheter connector.On (b)(6) 2024: for the same patient, when the device used on (b)(6) 2024 - that faced the incident was replaced, the extension luer tip broke off again and became stuck in the catheter connector.There was only one line remained on the catheter following the two successive breakages.Additional information: the line is still in the patient.There may have been an issue between the catheter and the extension line which was from another company.They are questioning the diameter of the leur hub of the extension line.There doesn't seem to be an issue with the teleflex catheter.The patient is reported as stable.Associated complaints: 3006425876-2024-00226.
Event or Problem Description
It was reported that: on (b)(6) 2024: after moving the patient, the nurse checked the lines and realized that the extension luer tip broke off and was stuck in the catheter connector.On (b)(6) 2024: for the same patient, when the device used on (b)(6)2024 - that faced the incident was replaced, the extension luer tip broke off again and became stuck in the catheter connector.There was only one line remained on the catheter following the two successive breakages.Additional information: the line is still in the patient.There may have been an issue between the catheter and the extension line which was from another company.They are questioning the diameter of the leur hub of the extension line.There doesn't seem to be an issue with the teleflex catheter.The patient is reported as stable.Associated complaints: 3006425876-2024-00225 and 3006425876-2024-00226.
Additional Manufacturer Narrative
(b)(4), complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the teleflex device, and no relevant findings were identified.It is noted that the customer reported the defect occurred with the non-teleflex doran component which was being used in conjunction with the teleflex catheter.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.

• Brand Name: CVC SET: 3-LUMEN 7 FR X 16 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18892468
• Report Number: 3006425876-2024-00225
• Device Sequence Number: 12309259
• Product Code: DQY
• UDI-Device Identifier: 10801902105223
• UDI-Public: 10801902105223
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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 Model Number: IPN918758
• Device Catalogue Number: CV-12703
• Device Lot Number: 71F23E1322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 04/05/2024
• Initial Report FDA Received Date: 03/13/2024
• Supplement Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• 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