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

Catalog Number	PR-41552-BAS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	01/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the catheter at the insertion point leaks intravenous fluids.Additional information: there was redness on the skin at the insertion site but there was no other harm or consequence to the patient.There was no medical intervention needed.The catheter was removed.
Event or Problem Description
It was reported that: the catheter at the insertion point leaks intravenous fluids.Additional information: there was redness on the skin at the insertion site but there was no other harm or consequence to the patient.There was no medical intervention needed.The catheter was removed.
Additional Manufacturer Narrative
Qn# (b)(4).The customer report of an insertion site leak was confirmed by visual inspection of the customer supplied video.The video shows a secured catheter in use with fluid leaking from the patient insertion site.However, full complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit warns 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." a device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PI MIDLINE 2L: 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18719671
• Report Number: 9680794-2024-00203
• Device Sequence Number: 12835956
• Product Code: PND
• UDI-Device Identifier: 10801902136586
• UDI-Public: 10801902136586
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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
• Device Expiration Date: 05/22/2025
• Device Catalogue Number: PR-41552-BAS
• Device Lot Number: 33F23H0145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2023
• 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: Male