MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN036440
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported on (b)(6) 2022, the female luer lock hub on the end of the lumen came off.The lumen had to be clamped and the catheter was replaced.No medical intervention was reported, and there was no patient injury or consequence reported.The patient's current condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one 3-l catheter for analysis.Signs of use in the form of dried biological material were observed on the catheter and inside the extension lines.Visual inspection of the catheter revealed both suture wings were torn.No other defects or anomalies were observed.None of the luer hubs were observed to be loose or have separated from the extension lines.No holes or cuts were observed on any of the extension lines or the catheter body.The catheter length measured 166 mm, which is within the specifications of 157-177 mm per product drawing.The distal extension line outer diameter measured 0.08639", which is within the specifications of 0.084"-0.088" per product drawing.The distal extension line inner diameter measured 0.057", which is within the specifications of 0.055"-0.059" per product drawing.The medial extension line outer diameter measured 0.08742", which is within the specifications of 0.084"-0.088" per product drawing.The medial extension line inner diameter measured 0.057", which is within the specifications of 0.055"-0.059" per product drawing.The proximal extension line outer diameter measured 0.08564", which is within the specifications of 0.084"-0.088" per product drawing.The proximal extension line inner diameter measured 0.059", which is within the specifications of 0.055"-0.059" per product drawing.Functional inspection of the catheter was performed per the product instructions for use (ifu) which states "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." each lumen was flushed using a lab inventory 10ml syringe.All lumens flushed normally.No leaks or blockages were observed while flushing any of the extension lines.A manual tug test confirmed all luer hubs were secured to their respective extension lines.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit 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/luer hub separation could not be confirmed through complaint investigation of the returned sample.Visual inspection revealed all luer hubs were present and secured to their respective extension lines.The catheter met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported on 13jul2022, the female luer lock hub on the end of the lumen came off.The lumen had to be clamped and the catheter was replaced.No medical intervention was reported, and there was no patient injury or consequence reported.The patient's current condition is reported as fine.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 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: 15520591
• Report Number: 9680794-2022-00620
• Device Sequence Number: 12269297
• Product Code: FOZ
• UDI-Device Identifier: 20801902117087
• UDI-Public: 20801902117087
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: 12/31/2023
• Device Model Number: IPN036440
• Device Catalogue Number: CDC-42703-XP1A
• Device Lot Number: 13F22D0098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 09/30/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• 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: N/A.; N/A.
• Patient Sex: Unknown