MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI AGBA PICC KIT: 2L 5.5FR X 55CM W/ VPS; CATHETER, INTRAVASCULAR, THERA

Catalog Number	ASK-45552-UWH1
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "i just placed a double lumen picc line in a patient with 1 arm to use.Rn flushed the white lumen prior to pulling it back, and it felt "sticky to pull back" but was able to pull back, trim and readvance.Picc was placed without issue, got a bullseye.Removed the doppler wire in the pink lumen and flushed with microclave.Tried to remove "buddy" wire that comes in the picc and could not remove it.Pulled again on the buddy wire and the end of the picc between the "0" mark and the hub folded like an accordion.Pulled the white lumen straight.I got out a stiff wire and inserted it in the white lumen which moved freely in and out of the catheter and then i was able to remove the "buddy wire".It seemed that it was "sticking" between the hub and the "0" mark.I had already broke away with my sheath and threw away my doppler wire so i had to get out a pizza box measure that doppler wire next to a stiff wire and try and reinsert this pizza box wire to see if i could get another bullseye after manipulating the picc line.I could not get the pizza box wire to thread all the way, so i ended up removing all wires and getting an cxr to confirm placement.I had a bullseye at "0" mark but on cxr it was 4cm to the caj".Additional information recieved states "the case went perfectly, and they had a blue bullseye initially.The issue started when they tried to remove the buddy wire that is manufactured with the picc.To clarify, the complaint is not in reference to a false bbe.The inserters believe the catheter migrated when they were trying to manipulate the wires." there was no patient harm or injury.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported that "i just placed a double lumen picc line in a patient with 1 arm to use.Rn flushed the white lumen prior to pulling it back, and it felt "sticky to pull back" but was able to pull back, trim and readvance.Picc was placed without issue, got a bullseye.Removed the doppler wire in the pink lumen and flushed with microclave.Tried to remove "buddy" wire that comes in the picc and could not remove it.Pulled again on the buddy wire and the end of the picc between the "0" mark and the hub folded like an accordion.Pulled the white lumen straight.I got out a stiff wire and inserted it in the white lumen which moved freely in and out of the catheter and then i was able to remove the "buddy wire".It seemed that it was "sticking" between the hub and the "0" mark.I had already broke away with my sheath and threw away my doppler wire so i had to get out a pizza box measure that doppler wire next to a stiff wire and try and reinsert this pizza box wire to see if i could get another bullseye after manipulating the picc line.I could not get the pizza box wire to thread all the way, so i ended up removing all wires and getting an cxr to confirm placement.I had a bullseye at "0" mark but on cxr it was 4cm to the caj".Additional information recieved states "the case went perfectly, and they had a blue bullseye initially.The issue started when they tried to remove the buddy wire that is manufactured with the picc.To clarify, the complaint is not in reference to a false bbe.The inserters believe the catheter migrated when they were trying to manipulate the wires." there was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI AGBA PICC KIT: 2L 5.5FR X 55CM W/ VPS
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: 23863733
• Report Number: 9680794-2025-01051
• Device Sequence Number: 13255350
• Product Code: LJS
• UDI-Device Identifier: 10801902217230
• UDI-Public: (01)10801902217230(11)250821(17)270111(10)33F25G0212(21)
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K112896
• 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): 11/25/2025

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 Catalogue Number: ASK-45552-UWH1
• Device Lot Number: 33F25G0212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2025
• 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