MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC KIT 1-LUMEN: 4.5 FR X 55CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-45541-HPK1A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported one side of the peel-away sheath broke off while attempting to separate the two halves.The sheath was removed and the procedure completed.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported one side of the peel-away sheath broke off while attempting to separate the two halves.The sheath was removed and the procedure completed.No patient harm reported.The patient's 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 it was not torn along the score lines as intended.One of the tabs separated from the main sheath body partway down the extrusion.The separation points were stretched and jagged.Functional inspection could not be accurately performed due to the condition of the returned sample.Manufacturing engineers confirmed the appearance of the damage is consistent with a manufacturing issue.A device history record review was performed, and several findings were identified.For part number eb-01042-002, batch 34c23f0030, five non-conformances were initiated regarding peel-away sheath damage.Based on the non-conformances and the returned sample, these findings are 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 along the score lines as intended.As a result, one of the tabs separated from the main peel-away sheath body.Based on these circumstances , and the comments from manufacturing, this issue is manufacturing related.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AGBA PICC KIT 1-LUMEN: 4.5 FR X 55CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 18000215
• Report Number: 9680794-2023-00795
• Device Sequence Number: 18051905
• Product Code: LJS
• UDI-Device Identifier: 30801902124075
• UDI-Public: 30801902124075
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K112896
• 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): 09/29/2023

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: 09/13/2024
• Device Catalogue Number: CDC-45541-HPK1A
• Device Lot Number: 33F23E0665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2023
• 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: 11/30/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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