MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AGBA PICC NAVICURVE: 1L 4.5FR X 55CM BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45541-CURVB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "after the sheath was inserted and the picc was threaded, the inserter tried to separate the tabs and one separated.The nurse was able to finish peeling the two sides of the sheath apart and complete the case".There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "after the sheath was inserted and the picc was threaded, the inserter tried to separate the tabs and one separated.The nurse was able to finish peeling the two sides of the sheath apart and complete the case".There was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The photo shows a peel-away sheath torn along its score lines with one tab appearing to have a portion of the extrusion attached.This supported the customer report that the tab, along with a portion of the extrusion, had separated prior to complete tearing of the sheath extrusion along the score lines.A device history record review was performed, and no relevant findings were identified.The customer report of peel away sheath tearing incorrectly was confirmed through investigation of the customer supplied photo.The photo shows a peel-away sheath torn along its score lines with one tab appearing to have a portion of the extrusion attached.This supported the customer report that the tab, along with a portion of the extrusion, had separated prior to complete tearing of the sheath extrusion along the score lines.Based on the customer report and the photo provided, manufacturing likely caused or contributed to this event.A non-conformance was created to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.

• Brand Name: AGBA PICC NAVICURVE: 1L 4.5FR X 55CM BP
• 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: 19339312
• Report Number: 9680794-2024-00466
• Device Sequence Number: 12545390
• Product Code: LJS
• UDI-Device Identifier: 10801902208696
• UDI-Public: 10801902208696
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: 01/24/2025
• Device Catalogue Number: DLX-45541-CURVB
• Device Lot Number: 33F23K0375
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2023
• 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