MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC SET: 4-L 8.5 FR X 6" (16 CM) AGB+; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	ASK-42854-PMC-S1
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the nurse was flushing cvc line when leaking at site noted.Line was removed from patient".Additional information reports, the catheter was removed from the patient and the patient is "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, 4-lumen cvc catheter for evaluation.Signs of use were observed on the catheter.A 10ml syringe was attached to the proximal luer hub.Visual examination of the catheter did not reveal any defects or anomalies such as kinks , holes, or cuts.The catheter length from the juncture hub to the distal tip measured 166 mm, which is within the specification limits of 157-177 mm per catheter product drawing.The catheter body outer diameter measured 2.86 mm, which is within the specification limits of 2.85-3.00 mm 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)." all extension lines were flushed with a lab inventory syringe filled with water.No leaks or blockages were detected.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 catheter was connected to 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.Therefore, the sample passed functional testing.A manual tug test confirmed all extension lines were fully secured within their respective hubs.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.No relevant findings were identified.The ifu provided with this kit warns the user, "do not alter the catheter, guidewire or any other kit/set component during insertion, use or removal.Some disinfectants used at catheter insertion site contain solvents which can weaken the catheter material.Alcohol, acetone, and polyethylene glycol can weaken the structure of polyurethane materials.These agents may also weaken the adhesive bond between catheter stabilization device and skin." the customer report of an insertion site leak could not be confirmed by complaint investigation of the returned sample.No defects or anomalies were observed on the returned sample.The catheter met all relevant dimensional and functional requirements including leak testing performed per bs en iso 10555-1.A device history record review was performed based on a potential lot from sales history, and no relevant findings were identified.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that "the nurse was flushing cvc line when leaking at site noted.Line was removed from patient".Additional information reports, the catheter was removed from the patient and the patient is "fine".

• Brand Name: ARROW PI CVC SET: 4-L 8.5 FR X 6" (16 CM) AGB+
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• 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: 19281580
• Report Number: 9680794-2024-00434
• Device Sequence Number: 6358483
• Product Code: FOZ
• UDI-Device Identifier: 10801902137170
• UDI-Public: 10801902137170
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: ASK-42854-PMC-S1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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