MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AM/AT PI MIDLINE 1L: 4.5 FR X 15 CM; MIDLINE CATHETER

Catalog Number	ASK-41541-LRM
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: patient came to ed with midline in place with complaint of leaking from extension line.Tubing noted to be possibly cut or separated? home health caring for line at patients' home.
Additional Manufacturer Narrative
(b)(4).The customer returned one midline catheter for analysis.Signs of use in the form of biological material were observed on the catheter body.Visual analysis revealed that the distal extension line appeared cut towards the luer hub.The cut almost completely severed the extension line; however, a portion of the extension line remained connected.Microscopic examination confirmed the damage and revealed that the edges were smooth and uniform.The appearance of the damage is consistent with contact with a sharp instrument (i.E.Scissors, scalpel, etc).The distal extension line outer diameter measured 0.095", which is within the specification limits of 0.093"-0.097" per the distal extension line extrusion product drawing.The distal extension line inner diameter measured 0.056", which is within the specification limits of 0.055"-0.059" per the distal extension line extrusion product drawing.A lab inventory syringe filled with water was attached to the distal extension line and flushed.Water was observed leaking from the hole.Performed per instructions-for-use (ifu) statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." a device history record review was performed, and no relevant findings were identified.The ifu provided with the 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 report of a leaking extension line was confirmed through complaint investigation.Visual and functional analysis revealed a hole/cut on the distal extension line.The edges of this hole/cut appeared smooth , uniform and consistent with damage resulting from contact with a sharp instrument (i.E.Scissors, scalpel, etc).Despite the damage, the sample met all relevant dimensional requirements.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: patient came to ed with midline in place with complaint of leaking from extension line.Tubing noted to be possibly cut or separated? home health caring for line at patients' home.

• Brand Name: AM/AT PI MIDLINE 1L: 4.5 FR X 15 CM
• 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: 18847365
• Report Number: 9680794-2024-00158
• Device Sequence Number: 15419058
• Product Code: PND
• UDI-Device Identifier: 10801902189353
• UDI-Public: 10801902189353
• 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
• Serviced by Third Party (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): 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: ASK-41541-LRM
• Device Lot Number: 33F23C0016
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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