MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC: 2L 5.5 FR X 45 CM; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	ASK-44552-ABKB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the handle of the peel away sheath broke off.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of a broken peel away sheath tab was confirmed by visual inspection of the returned sample and customer photos.The customer provided two photos and 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.Remains of the extrusion was still within the separated tab.The other tab was intact.It was also noted that the sheath was entirely peeled down both score lines as intended.The overall length of the sheath measured 2 3/4" via calibrated ruler which was within the specification limits of 2 5/8" - 2 7/8" per the sheath product drawing.The outer and inner diameter of the sheath could not be performed due to the condition of the returned sample.Functional inspection could not be performed due to the condition of the returned sample.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding, or component damage." a device history record review was performed, and a relevant finding was identified.Based on the customer report, sample received, and comments from manufacturing, the potential root cause of this event is manufacturing related.Further investigation has been initiated under teleflex's quality system by the manufacturing site to further investigate this issue.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: the handle of the peel away sheath broke off.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.Associated to 9680794-2023-00950.

• Brand Name: ARROW AGBA PICC: 2L 5.5 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18236206
• Report Number: 9680794-2023-00929
• Device Sequence Number: 6936121
• Product Code: LJS
• UDI-Device Identifier: 10801902140798
• UDI-Public: 10801902140798
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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: 11/29/2024
• Device Catalogue Number: ASK-44552-ABKB
• Device Lot Number: 33F23F0176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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