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	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "handle of sheath broke off during insertion.They opened a stand alone sheath." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "handle of sheath broke off during insertion.They opened a stand alone sheath." there was 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.A portion of the tab was also broken and separated.Remains of the extrusion was still within the separated tab.The other tab was intact.It was additionally noted that one score line was completely torn.The overall length of the 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 and inner diameters of the sheath could not be measured due to the damage.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.A non-conformance was created for part number eb-01052-002 with batch 34c23k0189 regarding "peel-away sheath tears incorrectly".The customer report of a broken peel away sheath tab was confirmed by visual inspection of the returned sample.The peel away sheath extrusion was separated directly adjacent to one tab.Based on the customer report and sample received, the root cause of this event is manufacturing related.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.Corrected data:.

• 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: 19536295
• Report Number: 9680794-2024-00576
• Device Sequence Number: 12368497
• Product Code: LJS
• UDI-Device Identifier: 10801902208702
• UDI-Public: 10801902208702
• 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): 05/22/2024

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 Catalogue Number: DLX-45552-CURVB
• Device Lot Number: 33F23A0335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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