MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-45703-XPN1A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "hole discovered during insertion, an over the wire exchange was performed without issue." there was no patient harm or injury.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 one, 3-lumen pressure-injectable cvc for analysis.Signs of use in the form of biological material were observed.After failing functional testing (see below), a small leak was detected on the extrusion of the proximal extension line.Microscopic examination confirmed that a hole was present at this location.The observed damage appears consistent to contact with a sharp object (i.E.Needle, scalpel, suture, etc).The hole on the proximal line measured 11mm from the white hub.The proximal extension line outer diameter measured 0.085", which is within the specification limits of 0.084"-0.088" per the proximal extension line extrusion product drawing.The proximal extension line inner diameter measured 0.056", which is within the specification limits of 0.055"-0.059" per the proximal extension line extrusion product drawing.The catheter body was clamped at the distal end.A lab inventory syringe filled with water was attached to all three extension lines and flushed.When flushing the proximal line, water was observed leaking out of the hole.No leaks were observed when flushing the medial or distal extension line.Performed per ifu statement, "flush lumen(s) to completely clear blood from catheter".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml (a fluid filled 1 ml syringe can exceed 300 psi) to reduce risk of intraluminal leakage or catheter rupture.".The ifu also states, "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 report of a leaking extension line was confirmed through complaint investigation of the returned sample.Visual and functional analysis revealed a leak on the proximal extension line.Despite the leaking, the catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.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 for reports of this nature.
Event or Problem Description
It was reported "hole discovered during insertion, an over the wire exchange was performed without issue." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 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: 22329491
• Report Number: 9680794-2025-00535
• Device Sequence Number: 8301048
• Product Code: FOZ
• UDI-Device Identifier: 10801902162042
• UDI-Public: (01)10801902162042(11)241205(17)251231(10)33F24K0002(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 12/31/2025
• Device Catalogue Number: CDC-45703-XPN1A
• Device Lot Number: 33F24K0002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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