BAXTER * 4681A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-27 for BAXTER * 4681A manufactured by Baxter Healthcare Corp..

Event Text Entries

[21592] Pt was cleaning tracheostomy tube with it in place and the stem on the cleaning brush broke leaving the brush stuck in the trach tube. Pt came to the hosp er where brush was removed from the trach tube without any adverse outcome.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 41738
• MDR Report Key: 41738
• Date Received: 1996-09-27
• Date of Report: 1996-09-19
• Date of Event: 1996-08-18
• Date Facility Aware: 1996-08-18
• Report Date: 1996-09-19
• Date Added to Maude: 1996-10-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BAXTER
• Generic Name: TRACHEOSTOMY CLEANING TRAY
• Product Code: EPE
• Date Received: 1996-09-27
• Model Number: *
• Catalog Number: 4681A
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 42788
• Manufacturer: BAXTER HEALTHCARE CORP.
• Manufacturer Address: HOSP SVC DIV DEARFIELD IL 60015 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1996-09-27