MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number	IPN918726
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the catheter was inserted in the right internal jugular on (b)(6) 2023.On (b)(6) 2023, the distal line was found separated at the level of the female luer hub.The distal line was clamped and a new catheter was inserted in the left internal jugular on (b)(6) 2023.It was reported there was no clinical consequence for the patient due to the event.Additional information received reports "patient deceased.Death is not related to the incident.Death is due to the pathology of the patient." the patient died on (b)(6) 2023.The cause of death is reported as "coma of unexplained origin in a patient with bladder cancer, progressing to non-resolving hydrocephalus despite the insertion of an external ventricular shunt, leading to the patient's death".
Event or Problem Description
It was reported the catheter was inserted in the right internal jugular on (b)(6) 2023.On (b)(6) 2023, the distal line was found separated at the level of the female luer hub.The distal line was clamped and a new catheter was inserted in the left internal jugular on (b)(6) 2023.It was reported there was no clinical consequence for the patient due to the event.Additional information received reports "patient deceased.Death is not related to the incident.Death is due to the pathology of the patient." the patient died on (b)(6) 2023.The cause of death is reported as "coma of unexplained origin in a patient with bladder cancer, progressing to non-resolving hydrocephalus despite the insertion of an external ventricular shunt, leading to the patient's death".
Additional Manufacturer Narrative
Qn# (b)(4).The complaint of extension line luer hub separation was able to be confirmed by the customer provided photos as they revealed the distal line separated from the luer hub.However, full 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.Warning: open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." a device history record review was performed, and no relevant findings were identified.Without the device returned for evaluation, 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: ARROW CVC SET: 4-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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17266987
• Report Number: 3006425876-2023-00635
• Device Sequence Number: 7911933
• Product Code: DQY
• UDI-Device Identifier: 10801902029239
• UDI-Public: 10801902029239
• 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): 06/08/2023

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
• Device Model Number: IPN918726
• Device Catalogue Number: CV-12854
• Device Lot Number: 71F23B2222
• 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: 06/08/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 07/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2023
• 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 Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 76 KG