MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number	IPN030863
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: incident occurred on (b)(6) 2023.Following a patient's slight agitation, the connection of the proximal catheter hub (white tip) broke and the luer lock tip separated.The separated tubing was immediately clamped.At the time of the separation, the proximal line was no longer used.Previous days of the incident, medication eupressyl and nimotop were infused via a syringe pump in the proximal line.There was no consequence for the patient.To solve the issue a new cv-12853 was inserted.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one luer hub for analysis.Signs of use were observed on the returned component.Visual inspection of the luer hub revealed it was separated from the proximal extension line.Remains of the extension line molding were observed on the luer hub.Visual inspection of the remainder of the catheter to evaluate the nature of the break could not be performed as it was not returned.The inner diameter of the proximal extrusion at the luer hub measured 1.45mm which is within the specifications of 1.42-1.50mm per product drawing.Functional inspection could not be performed without the remainder of the catheter returned.A device history record review was performed, and no relevant findings were identified.The ifu provided with the informs the user, "do not secure , staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".The ifu also states, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The customer report of an extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual inspection revealed the proximal luer hub had separated from the extension line extrusion.Remains of the extension line molding were observed on the luer hub.However, only the separated luer hub was returned and evaluation of the remainder of the catheter to determine the nature of the break could not be performed as it was not returned.A device history record review was performed with no relevant findings.Based on these circumstances, and without the complete sample returned for analysis , the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: incident occurred on (b)(6) 2023.Following a patient's slight agitation, the connection of the proximal catheter hub (white tip) broke and the luer lock tip separated.The separated tubing was immediately clamped.At the time of the separation, the proximal line was no longer used.Previous days of the incident, medication eupressyl and nimotop were infused via a syringe pump in the proximal line.There was no consequence for the patient.To solve the issue a new cv-12853 was inserted.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
• 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: 17504457
• Report Number: 3006425876-2023-00738
• Device Sequence Number: 6236241
• Product Code: DQY
• UDI-Device Identifier: 10801902000559
• UDI-Public: 10801902000559
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (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): 07/18/2023

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: 02/28/2026
• Device Model Number: IPN030863
• Device Catalogue Number: CV-12853
• Device Lot Number: 71F21G0413
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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: EUPRESSYL AND NIMOTOP - (B)(6) ; EUPRESSYL AND NIMOTOP - (B)(6)
• Patient Sex: Unknown