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

Catalog Number	CDC-41541-MPKB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the wings are breaking off as the sheath is being removed.There was no reported patient harm or consequence." associated complaint 9680794-2025-00060.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath and product lidstock for analysis.Signs of use in the form of biological material were observed on the sheath extrusion and tabs.Visual inspection revealed that the peel away sheath extrusion was separated directly adjacent to one tab.Microscopic examination confirmed the damage and revealed that the sheath was torn completely down both score lines.It was additionally noted that the tear was partially scalloped which is not the intended appearance of the score lines once torn.The total length of the sheath measured 2 3/4", which is within the specification limits of 2 5/8 - 2 7/8" per the sheath product drawing.The sheath outer and inner diameters could not be accurately measured due to the nature of the damage.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "precaution: avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis." 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 directly adjacent to one tab.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.
Event or Problem Description
It was reported that: "the wings are breaking off as the sheath is being removed.There was no reported patient harm or consequence." associated complaints 9680794-2025-00060.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21136475
• Report Number: 9680794-2025-00061
• Device Sequence Number: 6957522
• Product Code: PND
• UDI-Device Identifier: 10801902205411
• UDI-Public: (01)10801902205411(11)240918(17)251231(10)33F24J0021(21)
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 12/18/2024

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: 12/31/2025
• Device Catalogue Number: CDC-41541-MPKB
• Device Lot Number: 33F24J0021
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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