MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 50 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45041-VPS2
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter was placed midarm in the brachial vein and secured with a stat-lock.The next day, the patient was sitting in his chair when the nurse came in and saw it bleeding.The line completely separated from the pink lumen.Nurse reports that it was possible that it was tugged on/pulled when the patient was up in the chair but does not believe it should have been enough force to break off.The patient is fine and had no harm or injury.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one 1-l catheter for analysis.Definite signs of use were observed within the extension line and on the catheter body.Visual inspection of the returned sample revealed that the distal extension line was separated adjacent to the luer 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 separation in the extension line measured 42mm from the junction hub.The distal extension line outer diameter measured 0.0943", which is within the specification limits of 0.093" - 0.097" per the extension line product drawing.The distal extension line inner diameter measured 0.056" which is within the specification limits of 0.055-0.059" per the extension line product drawing.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 distal line had separated directly adjacent to the 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.
Event or Problem Description
It was reported that the catheter was placed midarm in the brachial vein and secured with a stat-lock.The next day, the patient was sitting in his chair when the nurse came in and saw it bleeding.The line completely separated from the pink lumen.Nurse reports that it was possible that it was tugged on/pulled when the patient was up in the chair but does not believe it should have been enough force to break off.The patient is fine and had no harm or injury.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 50 CM
• 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: 21332157
• Report Number: 9680794-2025-00119
• Device Sequence Number: 20811996
• Product Code: LJS
• UDI-Device Identifier: 60801902120740
• UDI-Public: (01)60801902120740(11)240830(17)251231(10)33F24D0363(21)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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: 12/31/2025
• Device Catalogue Number: CDC-45041-VPS2
• Device Lot Number: 33F24D0363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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: Male