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	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that venous access staff identified multiple dual lumen picc kits containing single lumen catheters.The associated emdr report numbers are 9680794-2025-00013, 9680794-2025-00017.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing 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 lid stock was reviewed as part of this complaint investigation.The lid stock for this product states, "pressure injectable arrowg+ard blue advance two-lumen picc kit pre-loaded with arrow vps precision stylet." the bill of materials additionally included a 2-l 5.5fr x 55cm catheter.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that venous access staff identified multiple dual lumen picc kits containing single lumen catheters.The associated emdr report numbers are 9680794-2025-00013, 9680794-2025-00017 and 9680794-2025-00016.

• 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: 21179761
• Report Number: 9680794-2025-00016
• Device Sequence Number: 15611027
• Product Code: LJS
• UDI-Device Identifier: 10801902217230
• UDI-Public: (01)10801902217230(11)240820(17)260106(10)33F24D0873(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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2026
• Device Catalogue Number: ASK-45552-UWH1
• Device Lot Number: 33F24D0873
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2024
• 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