MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 4FR X 8CM; CATHETER, PERCUTANEOUS

Catalog Number	CS-15403
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported the cvc was installed in a pediatric patient and "on day 4 of the installation, he presented a leak in one of the lumens"."during the hospitalisation, on (b)(6) 2023, a large leak was observed , apparently at the insertion site of the central venous catheter (cvc) located in the right subclavian artery installed on (b)(6) 2023.The state of the 3 lumens was checked by infusing physiological saline, with the proximal and distal lumen refluxing and infusing without difficulty , while the medial lumen showed an abundant outflow of saline.Sedation is administered to the patient for puncture and installation of a 13-cm, 3-lumen 4 fr central venous catheter (cvc), which is fixed with fixation points at the insertion site, one in both orifices of the cvc fixation system, at 10 cms.The 3 lumens reflux and infuse without difficulty.".
Event or Problem Description
It was reported the cvc was installed in a pediatric patient and "on day 4 of the installation, he presented a leak in one of the lumens"."during the hospitalisation, on (b)(6) 2023, a large leak was observed , apparently at the insertion site of the central venous catheter (cvc) located in the right subclavian artery installed on (b)(6) 2023.The state of the 3 lumens was checked by infusing physiological saline, with the proximal and distal lumen refluxing and infusing without difficulty , while the medial lumen showed an abundant outflow of saline.Sedation is administered to the patient for puncture and installation of a 13-cm, 3-lumen 4 fr central venous catheter (cvc), which is fixed with fixation points at the insertion site, one in both orifices of the cvc fixation system, at 10 cms.The 3 lumens reflux and infuse without difficulty.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

• Brand Name: ARROW CVC SET: 3-LUMEN 4FR X 8CM
• 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: 17646105
• Report Number: 3006425876-2023-00845
• Device Sequence Number: 8022057
• Product Code: DQY
• UDI-Device Identifier: 10801902027464
• UDI-Public: 10801902027464
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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: 10/31/2025
• Device Catalogue Number: CS-15403
• Device Lot Number: 71F22E6060
• 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: 08/07/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• 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