MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER

Catalog Number	CDC-41541-MPKC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported "white pull tab on break-away introducer came off while i was pulling it apart".The user reported the left side came off and the user "grabbed the remaining sheath and peeled it away".The sheath was removed in its entirety and the catheter was successfully placed in the left brachial vein.The patient's condition is reported as fine.
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 photo.The customer provided one photo for analysis and one tab appeared to be separated.The customer returned one peel away sheath for analysis.No 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.Functional inspection could not be performed due to the damage.Manufacturing unit confirmed that the damage was consistent with a manufacturing defect.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 for which further investigations were initiated for batches 34c23f0030 and 34c23e0162 for the "peel-away sheath tears incorrectly" failure.Based on the customer report, sample received, and comments from manufacturing, the potential root cause of this event was 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
Customer reported "white pull tab on break-away introducer came off while i was pulling it apart".The user reported the left side came off and the user "grabbed the remaining sheath and peeled it away".The sheath was removed in its entirety and the catheter was successfully placed in the left brachial vein.The patient's condition is reported as fine.

• Brand Name: ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM
• Common Device Name: MIDLINE 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17764640
• Report Number: 9680794-2023-00676
• Device Sequence Number: 7210173
• Product Code: PND
• UDI-Device Identifier: 10801902205435
• UDI-Public: 10801902205435
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• 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): 08/24/2023

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: 12/31/2024
• Device Catalogue Number: CDC-41541-MPKC
• Device Lot Number: 33F23D0743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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