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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "without much force, the midline extension broke free of the catheter.The patient had to get a new catheter.".The patient had no harm or injury.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one single-lumen midline catheter for analysis.Signs of use were observed on and within the returned catheter.Visual analysis revealed the extension line was separated adjacent to the juncture hub.Microscopic examination revealed the edges of the separation were rough and jagged, and a portion of the extension line remained within the juncture hub.The juncture hub was cross-sectioned to analyze the molding of the extension line within the juncture hub.The outer diameter of the line measured 0.094", which is within the specification limits of 0.093"-0.097" per extension line extrusion product drawing.The inner diameter of the extension line measured 0.058", which is within the specification limits of 0.055"-0.059" per extension line extrusion product drawing.Manufacturing was contacted as a part of this complaint investigation.They stated it is unknown whether the defect is related to the molding or the extrusion process; therefore, a non-conformance (nc) will be initiated to further investigate this issue.A device history record review was performed, and no relevant findings were identified.The instructions-for-use provided with this kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of a separated extension line was confirmed through complaint investigation of the returned sample.Visual and functional analysis revealed that the extension line was separated adjacent to the juncture hub, the edges of the separation were rough and jagged, and a portion of the extension line remained within the juncture hub.Despite this, the catheter passed all relevant dimensional requirements, and a device history record review revealed no relevant findings to suggest a manufacturing related issue.Based on these circumstances, manufacturing likely caused or contributed to this event.A non-conformance was initiated 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 "without much force, the midline extension broke free of the catheter.The patient had to get a new catheter." the patient had no harm or injury.

• 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: 21688797
• Report Number: 9680794-2025-00256
• Device Sequence Number: 21026217
• Product Code: PND
• UDI-Device Identifier: 10801902205411
• UDI-Public: (01)10801902205411(11)241026(17)260228(10)33F24H0359(21)
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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): 03/06/2025

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: 02/28/2026
• Device Catalogue Number: CDC-41541-MPKB
• Device Lot Number: 33F24H0359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2024
• 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