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); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "the picc line was placed and 18 hours later the line was leaking from the hub so they checked on it and were not able to aspirate so they removed it.When they removed it they discovered a bubble by the 35cm marking." a new picc line was inserted.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 actual device was not returned; however, the customer provided one photo for analysis.The complaint of a catheter body bulge was able to be confirmed by the photo.The image shows a catheter in a bag with evidence of a bulge deformation in the body, however, a complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.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, "use only lumen(s) labeled "pressure injectable" for pressure injection to reduce risk of catheter failure and/or patient complications.Refer to the arrow pressure injection information label for pressure injection information," and "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." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the picc line was placed and 18 hours later the line was leaking from the hub so they checked on it and were not able to aspirate so they removed it.When they removed it they discovered a bubble by the 35cm marking." a new picc line was inserted.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• 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: 23094724
• Report Number: 9680794-2025-00782
• Device Sequence Number: 21168872
• Product Code: LJS
• UDI-Device Identifier: 10801902208627
• UDI-Public: (01)10801902208627(11)250210(17)260331(10)33F24F0878(21)
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2025

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: 03/31/2026
• Device Catalogue Number: DLX-45552-VPSB
• Device Lot Number: 33F24F0878
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2025
• 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