MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI AGBA PICC KIT: 3-L 6 FR X 50 CM W/VPS; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45063-VPS2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "dilator wing broke off the sheath".No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "dilator wing broke off the sheath".No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The report of peel-away tabs breaking off was confirmed through analysis of the customer supplied photo.Visual analysis revealed that the sheath was split completely down the extrusion.One side of the extrusion appeared to separate directly adjacent to the tab.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the provided photo, manufacturing caused or contributed to this event.An investigation within teleflex was initiated to further investigate this complaint 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 50 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19078074
• Report Number: 9680794-2024-00329
• Device Sequence Number: 12269579
• Product Code: LJS
• UDI-Device Identifier: 50801902120774
• UDI-Public: 50801902120774
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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
• Device Expiration Date: 01/31/2025
• Device Catalogue Number: CDC-45063-VPS2
• Device Lot Number: 33F23K0410
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2024
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown