MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 5 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-12402
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "male patient with a central venous catheter has an external lumen leak".At the time of this report, the customer has not returned our requests for additional information.
Event or Problem Description
It was reported that "male patient with a central venous catheter has an external lumen leak".
Additional Manufacturer Narrative
(b)(4).Additional information received 11-aug-2024 indicates "there was no harm to the patient associated with the use".The catheter was replaced.It was also reported that the patient was "deceased - related to the underlying condition".The customer returned one, two-lumen cvc for analysis.Signs of use were observed on and within the catheter.Visual analysis did not reveal any defects or anomalies with the returned device.The catheter body length from the juncture hub to the distal tip measured 2 1/8", which is within the specification limits of 1 25/32"-2 3/16" per catheter product drawing.The catheter body outer diameter measured 0.055", which is within the specification limits of 0.054"-0.058" per catheter extrusion product drawing.The catheter was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a lab inventory syringe filled with water was attached to both extension lines and flushed.No leaks or blockages were observed when flushing either lumen.Both lumens flushed as intended.The returned catheter was then tested per bs en iso 10555-1 section 4.7.1 (amrq-000071 rev.15) which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 300 kpa for 30 seconds.The device was connected to a lab leak tester and pressurized to 300 kpa for 30 seconds with the distal end occluded.The extension lines were connected individually to the leak tester, and when pressurized, no catheter backflow or leaks were detected from any portion of the catheter, which indicates no inter lumen crossover was observed.Based on this testing, the customer issue could not be reproduced with the returned sample.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "ensure catheter patency prior to use.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 report of a leaking catheter body was not confirmed through complaint investigation of the returned sample.Both lumens passed functional leak testing performed per iso 10555-1 and no evidence of leakage , backflow, or inter lumen crossover was observed with any of the lumens.Based on the customer report and the testing of the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
Qn# (b)(4).Section h.6.-adverse event problem codes updated to reflect additional information received.Health effect - clinical code: 4582.Health effect - impact code: 2199, 4642.
Event or Problem Description
It was reported that "male patient with a central venous catheter has an external lumen leak".

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 5 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19943127
• Report Number: 9680794-2024-00743
• Device Sequence Number: 15307109
• Product Code: DQY
• UDI-Device Identifier: 30801902124310
• UDI-Public: (01)30801902124310(11)230612(17)271130(10)14F23F0052(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2024

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 Catalogue Number: CS-12402
• Device Lot Number: 14F23F0052
• 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: 07/11/2024
• Supplement Date Received by Manufacturer: 08/28/2024; Not provided
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 09/03/2024; 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• 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: N/A.; N/A.; N/A.
• Patient Age: 2 MO
• Patient Sex: Male