MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI AGBA PICC KIT: 3-L 6 FR X 55 CM W/VPS; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45563-VPS2
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the extension lumen hub broke off during the process of turning a patient.The line was discontinued and did not require replacement.The picc was then removed.The patient had no harm or injury.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one 3-l catheter for analysis.Definite signs of use were observed within the medial extension line and on the catheter body.Visual inspection of the returned sample revealed that the medial extension line was separated adjacent to the luer hub.It was additionally noted that the catheter body was severed approximately 42cm from the juncture hub.Microscopic examination confirmed the damage and revealed that the edges were jagged, and portions of the extension line extrusion were within the luer hub.The damage is consistent with a manufacturing molding issue.The medial extension line outer diameter measured 0.0965" which is within the specification limits of 0.093-0.097" per the extension line product drawing.The medial extension line inner diameter measured 0.058" which is within the specification limits of 0.055-0.059" per the extension line product drawing.A manual tug test confirmed the distal and proximal luer hubs were securely attached to their respective extension lines.A device history record review was performed with no relevant findings.The instructions-for-use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished , radiographic visualization should be obtained and further consultation requested." the report of a separated extension line from the luer hub was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the medial line had separated directly adjacent to the white luer hub, and portions of the extension line remained within the luer hub.The damage is consistent with a manufacturing molding issue.Based on the information provided and the sample received, manufacturing molding likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI AGBA PICC KIT: 3-L 6 FR X 55 CM W/VPS
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 21101185
• Report Number: 9680794-2025-00027
• Device Sequence Number: 21047037
• Product Code: LJS
• UDI-Device Identifier: 50801902120811
• UDI-Public: (01)50801902120811(11)240502(17)250928(10)33F24C0292(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• 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
• Report Date (Section B): 12/12/2024

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: 09/28/2025
• Device Catalogue Number: CDC-45563-VPS2
• Device Lot Number: 33F24C0292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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
• Patient Sex: Unknown