CODE BLUE EASI-LAV 1540 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-09 for CODE BLUE EASI-LAV 1540 * manufactured by Ballard Medical Products.

Event Text Entries

[145054] Lavage plunger (red side) pulled back and inside pieces snapped into small pieces.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015331
• MDR Report Key: 204571
• Date Received: 1998-12-09
• Date of Report: 1998-12-07
• Date of Event: 1998-12-07
• Date Added to Maude: 1999-01-06
• Event Key: 0
• Report Source Code: Voluntary 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CODE BLUE EASI-LAV
• Generic Name: ADULT GASTRIC LAVAGE SYSTEM 40 FR TUBE
• Product Code: KDH
• Date Received: 1998-12-09
• Model Number: 1540
• Catalog Number: *
• Lot Number: 32482
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 198694
• Manufacturer: BALLARD MEDICAL PRODUCTS
• Manufacturer Address: 12050 LONE PEAK PKWY DRAPER UT 84020 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-12-09