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.
Additional Manufacturer Narrative
(b)(4).The customer returned one opened ask-45552-uwh1 kit for evaluation.No signs of use were observed.Visual analysis revealed the returned catheter is a single-lumen 4.5 fr 55 cm catheter with vps, which is not the intended two-lumen 5.5 fr 55cm with vps catheter in finished good ask-45552-uwh1.The lidstock states, "pressure injectable arrowg+ard blue advance two-lumen picc kit pre-loaded with arrow vps precision stylet." no other defects or anomalies were observed.A device history record review was performed, and no relevant findings were identified.The customer report of an incorrect catheter was confirmed through complaint investigation of the returned sample.Visual inspection revealed the returned catheter is a single-lumen 4.5 fr 55 cm catheter with vps, which is not the intended two-lumen 5.5 fr 55cm catheter with vps in finished good ask-45552-uwh1.A device history record review was performed, and no relevant findings were identified.Based on these circumstances, packaging caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.
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: 21179706
• Report Number: 9680794-2025-00013
• Device Sequence Number: 17215276
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2025
• 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: 01/24/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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