MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC G4 STYLET: 2L 5.5FR X 55CM BP; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-45552-VPSB
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "double lumen picc placed on (b)(6) 2025, as of today bedside nurse had good blood return from both lumens, but when flushed, the pink lumen was leaking from a hole in the extension tube." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported a s "fine".
Event or Problem Description
It was reported that "double lumen picc placed on (b)(6) 2025, as of today bedside nurse had good blood return from both lumens, but when flushed, the pink lumen was leaking from a hole in the extension tube." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported a s "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, 2-lumen picc kit for analysis.Signs of use in the form of biological material were observed.A hole was observed in the distal extension line body.Microscopic examination confirmed that a hole was present at this location.The observed damage appears consistent to contact with a sharp object and or clamp (i.E.Needle, scalpel, needle holders, etc.).The hole on the distal line measured 26mm from the distal hub.The distal extension line outer diameter measured 0.094", which is within the specification limits of 0.093"-0.097" per the proximal extension line extrusion product drawing.The distal extension line inner diameter measured 0.057", which is within the specification limits of 0.055"-0.059" per the catheter product drawing.The distal end of the catheter body was clamped at the distal end.A lab inventory syringe filled with water was attached to both extension lines and flushed.When flushing the distal line, water was observed leaking out of the hole.No leaks were observed when flushing the proximal extension line.Performed per ifu statement, "ensure patency of each lumen of catheter prior to pressure injection to minimize the risk of catheter failure and/or patient complications." 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, "ensure catheter patency prior to use, including prior to pressure injection.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.Power injector equipment may not prevent over pressurizing an occluded or partially occluded catheter." the report of a leaking extension line was confirmed through complaint investigation of the returned sample.Visual and functional analysis revealed a hole/cut on the distal extension line.The observed damage appears consistent to contact with a sharp object and or clamp (i.E.Needle, scalpel, needle holders, etc.).Despite the leaking, the catheter met all relevant dimensional requirements.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.

• Brand Name: ARROW AGBA PICC G4 STYLET: 2L 5.5FR X 55CM BP
• 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: 23404614
• Report Number: 9680794-2025-00897
• Device Sequence Number: 4916135
• Product Code: LJS
• UDI-Device Identifier: 10801902208627
• UDI-Public: (01)10801902208627(11)250411(17)260430(10)33F25C0249(21)
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K123759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2025

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: 04/30/2026
• Device Catalogue Number: DLX-45552-VPSB
• Device Lot Number: 33F25C0249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown