MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN918787
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: cvc (central venous catheter) breaks during the turning of the patient in bed.The patient has a cvc in the groin.There are two "tips" or luer, one white and one brown.The white luer is connected to the tpn.When the staff turns the patient, the white luer becomes detached from the tubing.The tubing is clamped using forceps.An anesthesiologist is contacted and comes to the ward to examine the cvk.The cvk is removed, and a venous port is activated in consultation with the anesthesiologist.The anesthesiologist believes there is likely a problem with the material.The patient experienced distress but no symptomatic harm.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns 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.Do not alter the catheter, guidewire or any other kit/set component during insertion, use or removal." 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 that: cvc (central venous catheter) breaks during the turning of the patient in bed.The patient has a cvc in the groin.There are two "tips" or luer, one white and one brown.The white luer is connected to the tpn.When the staff turns the patient, the white luer becomes detached from the tubing.The tubing is clamped using forceps.An anesthesiologist is contacted and comes to the ward to examine the cvk.The cvk is removed, and a venous port is activated in consultation with the anesthesiologist.The anesthesiologist believes there is likely a problem with the material.The patient experienced distress but no symptomatic harm.

• Brand Name: CVC SET: 2-LUMEN 7 FR X 20 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18433702
• Report Number: 3006425876-2024-00014
• Device Sequence Number: 7023671
• Product Code: DQY
• UDI-Device Identifier: 00801902104960
• UDI-Public: 00801902104960
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 12/08/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN918787
• Device Catalogue Number: CS-17702-E
• Device Lot Number: 71F22A1646
• 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: 12/08/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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; NOT REPORTED
• Patient Sex: Unknown