MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AGBA PI MIDLINE 2-L: 5.5FR X 15CM; MIDLINE CATHETER

Catalog Number	CDC-41552-MPKB
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: "the peel away wings broke off during insertion making it very difficult to grip the remaining part of peel away sheath and remove.Completed the procedure with this difficulty.No adverse effects to patient or midline performance." associated complaints 9680794-2024-00639 and 9680794-2024-00638.
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 one side of the peel away sheath extrusion were separated adjacent to its tab.Remains of the extrusion were still attached to the separated tab.The sheath body was split completely down the extrusion.The peel-away sheath length from the tab to the distal end measured 2 3/4", which is within the specifications of 2 5/8" - 2 7/8" per product drawing.The outer and inner diameter of the sheath could not be accurately measured due to the condition of the returned sample.A device history record review was performed, and the following findings were identified: for part number eb-01052-002 batch 34c23k0189, two non conformances were initiated regarding a peel-away sheath torn incorrectly.Based on the sample received, these findings are potentially relevant to this investigation.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 vessel perforation and bleeding, or component damage".The report of a broken peel away sheath tab was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath extrusion had separated from one of the tabs.Based on the customer report and the sample received, manufacturing likely 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.Corrected data: section d.4.- unique identifier (udi)# corrected to (b)(4).
Event or Problem Description
It was reported that: "the peel away wings broke off during insertion making it very difficult to grip the remaining part of peel away sheath and remove.Completed the procedure with this difficulty.No adverse effects to patient or midline performance." associated complaints 9680794-2024-00639 and 9680794-2024-00638.

• Brand Name: AGBA PI MIDLINE 2-L: 5.5FR 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19642799
• Report Number: 9680794-2024-00638
• Device Sequence Number: 18276542
• Product Code: PND
• UDI-Device Identifier: 10801902205428
• UDI-Public: 10801902205428
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• Number of Events Summarized: 1
• Summary Report (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): 06/04/2024

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: 05/31/2025
• Device Catalogue Number: CDC-41552-MPKB
• Device Lot Number: 33F23K0405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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