MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM; INTRODUCER, CATHETER

Catalog Number	CDC-44041-VPS2
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
It was reported that: the tab of the peel away sheath snapped off while attempting to peal it apart.It happened during use on patient but there was no reported patient harm or consequence.
Additional Manufacturer Narrative
(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 it was not torn along the score lines as intended.A segment of the peel-away sheath was completely separated.The separation points were stretched and jagged.The length of the sheath body measured 2 3/4" , which is within the specification limits of 2 5/8"-2 7/8" per the sheath peel-away extrusion product drawing.Functional inspection could not be accurately performed due to the condition of the returned sample.A device history record review was performed, and a finding was identified.It was determined that the finding is relevant to this investigation.The customer report of a peel-away sheath torn incorrectly was confirmed through complaint investigation of the returned sample.Visual inspection revealed the sheath did not tear correctly along the score lines.Based on these circumstances, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: the tab of the peel away sheath snapped off while attempting to peal it apart.It happened during use on patient but there was no reported patient harm or consequence.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 40 CM
• Common Device Name: INTRODUCER, CATHETER
• 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: 17709746
• Report Number: 9680794-2023-00646
• Device Sequence Number: 14012167
• Product Code: LJS
• UDI-Device Identifier: 50801902120699
• UDI-Public: 50801902120699
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 07/22/2024
• Device Catalogue Number: CDC-44041-VPS2
• Device Lot Number: 33F23C0391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown