MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC NAVICURVE: 2L 5FR X 55CM W BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-35552-CURVB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "glide-thru sheath handles broke off during insetion of picc line".No patient harm or injury.No medical intervention required.The patient's current condition is reported as"fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one peel away sheath for analysis.Definite signs of use were observed.Visual analysis revealed that one peel away sheath extrusion was separated directly adjacent to the tab.Remains of the extrusion were still within the separated tab.The other tab was intact.It was also noted that the sheath was entirely peeled down both score lines as intended.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.The outer and inner diameter of the sheath could not be performed due to the condition of the returned sample.Functional inspection could not be performed due to the condition of the returned sample.A device history record review was performed, and a relevant finding was identified.Non-conformance was initiated for batch to address the issue of a peel-away tearing incorrectly.The ifu provided with the kit informs the user, "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 customer report of a broken peel away sheath tab was confirmed by visual inspection of the returned sample.One peel away sheath extrusion was separated directly adjacent to the tab.Based on the customer report and the sample received, the root cause of this event is manufacturing related.Non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.Corrected data: section d.4.Unique identifier (udi)# corrected to (b)(4).
Event or Problem Description
It was reported "glide-thru sheath handles broke off during insetion of picc line".No patient harm or injury.No medical intervention required.The patient's current condition is reported as"fine".

• Brand Name: ARROW PI PICC NAVICURVE: 2L 5FR X 55CM W 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19444866
• Report Number: 9680794-2024-00543
• Device Sequence Number: 15595262
• Product Code: LJS
• UDI-Device Identifier: 10801902208764
• UDI-Public: 10801902208764
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/08/2024

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: 11/30/2024
• Device Catalogue Number: DLX-35552-CURVB
• Device Lot Number: 33F23G0142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 06/02/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown