MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 7 FR X 60 CM; CATHETER PERCUTANEOUS

Catalog Number	AK-17753-J
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during placement of the catheter, the three-way stopcock was found broken and the medical agent was found leaking.Therefore, the stopcock was replaced with a new one from another kit.No injury to the patient occurred." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned three 3-way stopcocks for analysis.It is assumed that all three stopcocks were from the same kit.Signs of use were observed inside all three stopcocks.Visual analysis revealed severe cracking on proximal-most connector for all three stopcocks.The appearance of the crack is consistent with over tightening or repeated tightening of the hub.Microscopic examination confirmed the cracking.The stopock was connected to a lab inventory catheter and flushed using a lab inventory syringe.A leak was observed at the location of the crack on all three stopcocks.Performed per ifu statement , "connect all extension line(s) to appropriate luer-lock connector(s) as required.Unused port(s) may be "locked" through luer-lock connector(s) using standard institutional policies and procedures".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "air embolism can occur if air is allowed to enter a central venous access device or vein.Do not leave open needles or uncapped, unclamped catheters in central venous puncture site.Use only securely tightened luer-lock connections with any central venous access device to guard against inadvertent disconnection".The customer report of a leaking stopcock was confirmed through investigation of the returned samples.Visual and functional testing revealed a crack on all three stopcocks.The appearance of the crack is consistent with over-tightening of the hub.A device history record review was performed with no relevant findings.Therefore, 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 on reports of this nature.
Event or Problem Description
It was reported "during placement of the catheter, the three-way stopcock was found broken and the medical agent was found leaking.Therefore, the stopcock was replaced with a new one from another kit.No injury to the patient occurred." there was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 60 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: 20634260
• Report Number: 3006425876-2024-01074
• Device Sequence Number: 7432113
• Product Code: DQY
• UDI-Device Identifier: 00801902101976
• UDI-Public: (01)00801902101976(11)221121(17)241031(10)71F22L0783(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/15/2024

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
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: AK-17753-J
• Device Lot Number: 71F22L0783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2022
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown