MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	ASK-45552-RH
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "fluid leaking from the external clear portion of the white lumen, a few mm from the hub." additional information provided includes "i originally attempted to exchange over wire to minimize procedure time but could not get the last 4-6cm of the new picc to advance.When he became unable to tolerate my troubleshooting, i aborted the exchange attempt out of concern for maintaining my sterile field.Md asked me to try on the left, and that procedure went smoothly." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-lumen catheter for analysis.Signs of use were observed.The catheter was trimmed at the 6cm mark and 2 trimmed portions of the catheter were returned as well.Following leaking observed in the functional analysis, visual inspection confirmed a small hole was present in the proximal extension line distal to the luer hub.Microscopic examination of the proximal extension line confirmed the damage.The appearance of the hole is consistent with damage resulting from contact with a sharp instrument (i.E.Scalpel, scissors, etc).No other defects or anomalies were observed on the catheter.The outer diameter of the proximal extension line measured 0.094", which is within the specification limits of 0.093" - 0.097" per proximal extension line extrusion drawing.The inner diameter of the proximal extension line measured 0.057" , which is within the specification limits of 0.055" - 0.059" per proximal extension line extrusion drawing.The hole was measured 4mm from the proximal extension line luer hub.The catheter was functionally tested per the instructions for use (ifu) provided with this kit , which instructs the user "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the catheter flushed as intended, and no leaks were observed.The returned catheter was then tested per bs en iso 10555-1 section 6.8 (amrq-000008) which states that "there shall be no liquid leakage in the form of a falling drop of water at 300 to 320 kpa (43.5 to 46.4 psi) for 30 seconds." the extension lines of the catheter were individually connected to a leak tester and pressurized to 300 kpa for 30 seconds.One minor leak was observed on the proximal extension line at the location of the hole.A manual tug test confirmed that the extension line remained attached to the luer hub despite the hole in the extension line.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit informs 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 report of an extension line leak was confirmed through investigation of the returned sample.Functional inspection of the catheter revealed the proximal extension line contained a hole distal to the luer hub.During functional testing, water leaked from the hole in the proximal extension line.Based on the customer report , the returned sample, and previous complaints of this nature, unintentional contact with sharps likely cause or contributed to this event.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that "fluid leaking from the external clear portion of the white lumen, a few mm from the hub." additional information provided includes "i originally attempted to exchange over wire to minimize procedure time but could not get the last 4-6cm of the new picc to advance.When he became unable to tolerate my troubleshooting, i aborted the exchange attempt out of concern for maintaining my sterile field.Md asked me to try on the left, and that procedure went smoothly." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PICC KIT: 2L 5.5 FR X 55 CM CG+ VPS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 23693221
• Report Number: 9680794-2025-00999
• Device Sequence Number: 9124086
• Product Code: LJS
• UDI-Device Identifier: 10801902159967
• UDI-Public: (01)10801902159967(11)250531(17)260731(10)33F25D0361(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2025

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: 07/31/2026
• Device Catalogue Number: ASK-45552-RH
• Device Lot Number: 33F25D0361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2025
• 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
• Patient Sex: Unknown