MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2L 5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14502
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "in icu, the nurse found the extension line was leaking during use on the patient.After that they remove the catheter." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "in icu, the nurse found the extension line was leaking during use on the patient.After that they remove the catheter." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, 2-lumen catheter for analysis.Signs of use were observed on and within the catheter.Initial visual did not reveal any obvious defects or anomalies on the returned catheter.After failing functional testing, visual analysis revealed a hole on the proximal extension line towards the juncture hub.Microscopic analysis confirmed the damage, and the edges of the hole appeared smooth and uniform which is consistent with contact with a sharp instrument (i.E.Scissors , scalpel, etc.).The hole in the proximal extension line measured 22 mm from the juncture hub.The proximal extension line outer diameter measured 0.088", which is within the specification limits of 0.084"-0.088" per proximal extension line extrusion product drawing.The proximal extension line inner diameter measured 0.059", which is within the specification limits of 0.055"-0.059" per proximal extension line extrusion product drawing.The catheter body length from the juncture hub to the distal tip measured 5", which is within the specifications of 4 13/16"-5 3/16" per catheter 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 each extension line.The distal extension line flushed as intended.Leaking was observed from a hole in the proximal extension line when it was flushed.A manual tug test confirmed both lumens were secured to their respective hubs.A device history record review was performed, and no relevant findings were identified.The ifu provided with these kits 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." the customer report of an extension line leak was confirmed through complaint investigation of the returned sample.Functional and visual inspection revealed a hole on the proximal extension line extrusion.The edges of the hole were smooth and appeared consistent with contact with a sharp instrument (i.E.Scalpel, scissors , etc.).The catheter met all relevant dimensional requirements.A device history record review was performed , and no relevant findings were identified.Based on these circumstances, unintentional use error (contact with sharps) likely caused or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: ARROW CVC SET: 2L 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: 20129774
• Report Number: 3006425876-2024-00872
• Device Sequence Number: 20687192
• Product Code: DQY
• UDI-Device Identifier: 30801921122939
• UDI-Public: (01)30801921122939(11)230922(17)280831(10)71F23J0846(21)
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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-14502
• Device Lot Number: 71F23J0846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown