MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. - LAREDO NEURO EMBO TRAY; NEUROLOGICAL TRAY

Lot Number 21HBO722

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 09/30/2021

Event Type  malfunction  

Event Description

A provider was performing an intracranial embolization on a patient.During the procedure, the provider noticed that there were fine fibers on the microwire used for the embolization.It was felt that the fibers were likely from the drapes (which had recently been changed by the supplier).The drapes were included in a neuro embo tray kit and all the stocked kits were checked and those with the same lot number were removed.Fda safety report id # (b)(4).

• Brand Name: NEURO EMBO TRAY
• Type of Device: NEUROLOGICAL TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. - LAREDO
• MDR Report Key: 12590030
• MDR Text Key: 275891897
• Report Number: MW5104450
• Device Sequence Number: 1
• Product Code: OJG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/29/2024
• Device Lot Number: 21HBO722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR