MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN056359
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "broken tubing black port leaking".No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "broken tubing black port leaking".No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one 3-l picc for analysis.Signs of use were observed on the catheter.Visual analysis of the returned catheter did not reveal any defects or anomalies.No holes or tears were observed on any location of the catheter.The distal end of the catheter extrusion appeared to be intentionally severed.The outer diameter of the distal extension line measured 0.09525", (b)(4).The medial extension line outer diameter measured 0.09525", (b)(4).The inner diameter measured 0.059", (b)(4).The proximal extension line od measured 0.09660", (b)(4).The inner diameter measured 0.059", (b)(4).The catheter was functionally tested per the instructions for use (ifu)provided with this kit which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen (s)." the distal end of catheter extrusion was occluded, and the extension lines were flushed using lab inventory syringe.No leaks were observed in any of the extension lines or catheter body.The returned catheter was then tested per (b)(4) which states that there shall be no liquid leakage in the form of a falling drop of water at 300-320 kpa (43.5-46.4 psi) for 30 sec when tested per (b)(4).Each of the catheter extension lines were connected to lab leak tester and pressurized to 300 kpa for 30 seconds.No leaks were observed from any region of the catheter.A manual tug test confirmed that the extension lines were secure within their respective luer hubs.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the customer report of a leaking extension line could not be confirmed by investigation of the returned sample.The returned catheter passed functional leak testing performed per bs en iso-10555-1.The catheter passed all relevant dimensional and functional requirements, and a device history record review revealed no relevant findings.Based on the customer report and the returned sample, no problem was found.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS
• 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: 16409310
• Report Number: 9680794-2023-00091
• Device Sequence Number: 5759412
• Product Code: LJS
• UDI-Device Identifier: 10801902161793
• UDI-Public: 10801902161793
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K122545
• 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): 01/25/2023

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: 09/30/2023
• Device Model Number: IPN056359
• Device Catalogue Number: ASK-45563-UWH
• Device Lot Number: 13F22D0159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown