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

Catalog Number CDC-41541-MPK1A

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2022

Event Type  Injury  

Event Description

It was reported the user was placing a midline and lost control of the wire.The wire was embolized into the patient's vein and retrieved by interventional radiology using a snare.It was reported the patient is fine.

Manufacturer Narrative

(b)(4).

Event Description

It was reported the user was placing a midline and lost control of the wire.The wire was embolized into the patient's vein and retrieved by interventional radiology using a snare.It was reported the patient is fine.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed, and a potentially relevant finding was identified.A non-conformance was initiated for batches 13c21h1827, 13c21h1829, and 13c21b1929, to address the issue of a leaking extension line.Despite this, based on the customer report for this complaint that they "lost control of the wire", it was concluded that this is not the same issue being addressed within the relevant finding.Without the device to evaluate the complaint could not be confirmed and 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 AM/AT PI MIDLINE 1-L: 4.5FR X 15C
• Type of Device: 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: 13941308
• MDR Text Key: 288134016
• Report Number: 9680794-2022-00193
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: CDC-41541-MPK1A
• Device Lot Number: 13F21J0517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention