MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC NAVICURVE: 1L 4FR X 55CM W BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-35541-CURVB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "peel away sheath is facturing at the white wings were you peel it.One wing is consistently falling off thus creating a risk to patients." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "peel away sheath is facturing at the white wings were you peel it.One wing is consistently falling off thus creating a risk to patients." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one peel-away sheath for evaluation.Signs of use were observed.Visual inspection of the peel-away sheath revealed that the sheath had split completely down the length of the extrusion.One of the tabs did not tear correctly resulting in the extrusion to separate, but with a portion of the extrusion remaining attached to the tab.The separation points of the extrusion appeared stretched.The other tab was separated from the sheath extrusion and was not re-turned.The sheath extrusion portions from the side that tore incorrectly measured 2 1/2" and 3/4", totaling 3 1/4", which is not within the specification limits of 2 5/8"-2 7/8" per peel-away product drawing.This is likely due to the stretching observed at the points of separation.The sheath outer diameter/inner diameter could not be accurately measured.Functional inspection could not be accurately performed due to the condition of the returned sample.A device history record review was per-formed, and no relevant findings were identified.The report that a peel-away did not tear correctly was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath split completely along the score lines; however, one side of the extrusion had separated with a portion of the extrusion remaining attached to the tab.Based on the customer report and the sample received, manufacturing caused or contributed to this event.Nonconformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: unique identifier (udi)# corrected from (b)(4).

• Brand Name: ARROW PI PICC NAVICURVE: 1L 4FR 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: 19475784
• Report Number: 9680794-2024-00539
• Device Sequence Number: 4071336
• Product Code: LJS
• UDI-Device Identifier: 10801902208757
• UDI-Public: 10801902208757
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/14/2024

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-35541-CURVB
• Device Lot Number: 33F23G0145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2023
• 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