MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC G4 STYLET: 1L 4.5FR X 55CM TCG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-45541-VPSC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one dilator for analysis.Definite signs of use were observed on the dilator body and within the hub.Visual analysis revealed that the dilator body separated at the hub.The separation point appeared smooth, and signs of adhesive were visible on the dilator separation point.No remains of the dilator were visible within the hub.The overall length of the dilator measured 3 3/4" which is within the specification limits of 3 5/8 - 3 7/8" per the dilator product drawing.The outer diameter of the dilator measured 0.06375 which is within the specification limits of 0.063 - 0.065" per the dilator product drawing.Functional testing could not be performed due to the circumstances of the returned sample.A device history record review was performed, and no relevant findings were identified.The customer report of a dilator hub separation was confirmed through investigation of the returned sample.The dilator extrusion was separated at the hub.Visual inspection of the point of separation revealed that no dilator hub material was present in the separated hub.Based on the customer report and the sample received, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported "sheath introducer broke after removing from the patient during a procedure." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW AGBA PICC G4 STYLET: 1L 4.5FR X 55CM TCG
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20452611
• Report Number: 9680794-2024-01019
• Device Sequence Number: 20986760
• Product Code: LJS
• UDI-Device Identifier: 10801902208610
• UDI-Public: (01)10801902208610(11)240416(17)251031(10)33F24B0527(21)
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K122545
• 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
• Report Date (Section B): 09/18/2024

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: 10/31/2025
• Device Catalogue Number: DLX-45541-VPSC
• Device Lot Number: 33F24B0527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• 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.
• Patient Sex: Unknown