MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45552-CURVB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "peel away sheath that did not break apart, the plastic wing broke off".The patient had no harm or injury.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided one image for analysis.The image shows the peel-away sheath and dilator contained in a biohazard bag.The complaint of the tab breaking off was confirmed by the customer-provided image.The customer also returned one peel-away sheath and dilator for analysis.The sheath was observed to have one tab separated from the device.The point of separation was discolored, partially melted and deformed.Obvious signs of use in the form of biological material were observed on the sheath and dilator.The overall length of one sheath measured 2 3/4", which is within the specification limits of 2 5/8" - 2 7/8" per the sheath product drawing.The outer diameter of the sheath measured 0.0835" which is within the specification limits of 0.078" - 0.084" per the sheath extrusion drawing.The inner diameter of the sheath measured 0.071" which is within the specification limits of 0.066" - 0.071" per the sheath extrusion drawing.The sheath was functionally tested per the instructions for use (ifu) provided with this kit which instructs the user, "ensure dilator is in position and locked to hub of sheath." the dilator was then reinserted into the sheath.One side of the dilator hub locked into one of the sheath tabs as intended.Since the other tab was missing, the opposite tab of the dilator hub did not lock in.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit informs the user , "precaution: avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis." the customer report of a broken peel-away sheath tab was confirmed through the investigation of the returned sample.The sheath was analyzed, and one tab had separated from the body of the device and was not returned.The point of separation was discolored, melted and deformed.Manufacturing engineering was contacted regarding this issue, and it was determined that manufacturing caused or contributed to the reported 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 "peel away sheath that did not break apart, the plastic wing broke off".The patient had no harm or injury.

• Brand Name: ARROW AGBA PICC NAVICURVE: 2L 5.5FR 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: 21356235
• Report Number: 9680794-2025-00141
• Device Sequence Number: 18132369
• Product Code: LJS
• UDI-Device Identifier: 10801902208702
• UDI-Public: (01)10801902208702(11)241022(17)260227(10)33F24F0944(21)
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: 02/27/2026
• Device Catalogue Number: DLX-45552-CURVB
• Device Lot Number: 33F24F0944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Supplement Date Received by Manufacturer: 03/13/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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: Unknown