MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 5.5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-16553-E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the extension line was found leaking during use on the patient.The patient's condition is reported as fine.
Event or Problem Description
It was reported the extension line was found leaking during use on the patient.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one, 3-lumen cvc for analysis.Signs of use in the form of biological material were observed on the sample.After failing functional analysis, a small hole was observed around the middle of the extrusion.Microscopic examination confirmed the damage and revealed that the edges were smooth and uniform.The observed defect seems consistent with damage due to contact with sharps (i.E.Scalpel, scissors, etc.).The extension line outer diameter measured 0.086", which is within the specification limits of 0.084"-0.088" per the distal extension line extrusion product drawing.The distal extension line inner diameter measured 0.057", which is within the specification limits of 0.055"-0.059" per the distal extension line extrusion product drawing.The distal end of the catheter body was occluded and all three of the extension lines were pressurized with a lab inventory syringe.When pressurizing the distal extension line, water was observed leaking out of a small hole around the middle of the extrusion.Performed per ifu statement, "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed".No leaks were observed when flushing the proximal and medial extension lines.A manual tug test confirmed that all three extension lines were secure within their respective luer hub.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit 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 report of a leaking extension line was confirmed through complaint investigation.Visual and functional analysis confirmed a small hole on the distal extension line.The appearance of the defect is consistent with damage due to contact with sharps.Despite the damage, the catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5 FR X 13 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17645605
• Report Number: 3006425876-2023-00848
• Device Sequence Number: 7978851
• Product Code: DQY
• UDI-Device Identifier: 30801931122981
• UDI-Public: 30801931122981
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: 10/28/2025
• Device Catalogue Number: CS-16553-E
• Device Lot Number: 71F20K2050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• 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: 09/22/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2020
• 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