MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC: 1L 4.5 FR X 45 CM; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	ASK-44541-ABKB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported while attempting to peel the peel-away sheath, one side of the white sheath hub broke off.Clinician used the leverage of the picc and one white wing to continue to peel the sheath even though the other white hub broke off.Procedure completed without needing to drop an additional sheath.The patient's condition is reported as fine.
Event or Problem Description
It was reported while attempting to peel the peel-away sheath, one side of the white sheath hub broke off.Clinician used the leverage of the picc and one white wing to continue to peel the sheath even though the other white hub broke off.Procedure completed without needing to drop an additional sheath.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer provided one image showing a defective peel-away sheath.Signs of use were observed.The customer also returned one peel-away sheath for analysis.Signs of use in the form of biological material was observed.Visual analysis revealed that one of the tabs did not tear correctly along the seam lines.This resulted in the extrusion to separate.Further analysis revealed that one of the score lines was completely separated down the entire extrusion.The sheath body was cross sectioned to better visualize the divots for the seam lines.The sheath body length from the tabs to the distal tip measured 2 3/4" , which is within the specification limits of 2 5/8"-2 7/8" per the peel-away product drawing.The sheath outer diameter/inner diameter could not be accurately measured as one of the seam lines was already split.R & d was contacted as part of this complaint investigation.They confirmed that the failure for this complaint is consistent with an extrusion defect.A device history record review was performed, and a relevant finding was identified.A non-conformance was initiated to address the issue of peel-away sheath tears 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 report that a peel-away did not tear correctly was confirmed through complaint investigation.Visual analysis revealed that the sheath split incorrectly along one of the score lines.Despite the damage, the sheath met all relevant dimensional requirements.Based on the customer report, the sample received, and the comments from r & d, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC: 1L 4.5 FR X 45 CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• 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: 17849438
• Report Number: 9680794-2023-00713
• Device Sequence Number: 7173530
• Product Code: LJS
• UDI-Device Identifier: 10801902140781
• UDI-Public: 10801902140781
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: ASK-44541-ABKB
• Device Lot Number: 33F23D0702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 10/01/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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