BARD *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-12-28 for BARD * manufactured by Cr Bard, Inc. Bard Access Systems.

Event Text Entries

[199782] Noted 1 cm laceration in right side of soft palate approx 2cm in length and gaping open. Neonatal consult ordered; ampicillin ordered prophylactically. Infant had been suctioned at birth using bard (2 oz with slim tip) ear and ulcer syringe.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1020699
• MDR Report Key: 310379
• Date Received: 2000-12-28
• Date of Report: 2000-12-14
• Date of Event: 2000-12-13
• Date Added to Maude: 2001-01-03
• 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: BARD
• Generic Name: EAR & ULCER SYRINGE
• Product Code: EIB
• Date Received: 2000-12-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 300271
• Manufacturer: CR BARD, INC. BARD ACCESS SYSTEMS
• Manufacturer Address: 5425 W AMELIA EARHART DR SALT LAKE CITY UT 84116 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-12-28