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

Catalog Number	DLX-45552-CURVB
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer provided one image showing the peel-away sheath.The edges of the extrusion were wavy and not uniform.This is an indicator that the sheath did not tear correctly.The customer returned one peel-away sheath.The dilator was not returned.Signs of use were observed on the peel-away tabs.Visual analysis revealed that the peel-away was split completely down the extrusion.Both sides of the extrusion were intact.No separations were observed; however, microscopic examination revealed that the edges were wavy and not uniform.This is an indicator that the sheath did not tear as it is intended.The overall length of the sheath measured 2 13/16", which within the specification limits of 2 5/8 - 2 7/8" per the sheath product drawing.The outer and inner diameters of the sheath could not be accurately measured due to the condition of the returned sample.Functional testing could not be performed due to the condition of the returned sample.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis".The ifu also states, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding, or component damage".The report of a peel-away sheath tearing incorrectly was confirmed through complaint investigation.Visual examination revealed that the sheath was split along the entire extrusion; however, the edges of the split were rough and jagged.The sheath met all relevant dimensional requirements.The appearance of the defect is consistent with damage due to a manufacturing process.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 "when the two sides of the peel-away sheath were separated, it was noted that one of the seams in the sheath had appeared to have separated irregularly and had a a serrated edge.The device functioned normally but had an abnormal appearance." 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 NAVICURVE: 2L 5.5FR X 55CM BP
• 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: 19444861
• Report Number: 9680794-2024-00512
• Device Sequence Number: 14266223
• Product Code: LJS
• UDI-Device Identifier: 10801902208702
• UDI-Public: 10801902208702
• Combination Product (Y/N): N
• PMA/510(K) Number: K123759
• 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): 05/07/2024

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: DLX-45552-CURVB
• Device Lot Number: 33F24A0335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 06/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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