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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "tab broke from sheath while attempting to peel sheath.The inserter was able to peel away the sheath with the single tab".The patient had no harm or injury.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath for analysis.Signs of use in the form of biological material were observed.Visual inspection revealed that one side of the peel-away sheath tabs tore at the tab, causing the tab to separate from the rest of the assembly.The sheath extrusion appeared stretched at the site of separation.Microscopic examination confirmed the damage and revealed that the sheath was torn completely down one scoreline.The sheath was severed to observe the cross-section.The overall length of the sheath measured 2 13/16", which is within the specification limits of 2 5/8" - 2 7/8" per the sheath product drawing.Functional inspection could not be accurately performed as a part of this complaint investigation due to the condition of the returned sample.Manufacturing was consulted as a part of this complaint investigation.They confirmed the defect is likely related to a loose core pin that damaged cavity #1 during the manufacturing process.A device history record review was performed, and no relevant findings were identified.The instructions for use (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 report of peel-away tabs breaking off in use was confirmed through complaint investigation of the returned sample.Visual analysis revealed that one side of the peel-away sheath tabs tore at the tab, causing the tab to separate from the rest of the assembly.Microscopic examination revealed that the sheath was torn completely down one scoreline.Manufacturing was consulted as a part of this complaint investigation, and they confirmed the defect is a manufacturing process issue.Therefore, 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 complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "tab broke from sheath while attempting to peel sheath.The inserter was able to peel away the sheath with the single tab".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: 21477465
• Report Number: 9680794-2025-00196
• Device Sequence Number: 14344520
• Product Code: LJS
• UDI-Device Identifier: 10801902208702
• UDI-Public: (01)10801902208702(11)241102(17)260227(10)33F24K0472(21)
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• 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): 02/14/2025

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: 33F24K0472
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2024
• 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