BALLARD CLOSED CIRCUIT DRAIN PROBE AND Y ADAPTER 132

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-08-04 for BALLARD CLOSED CIRCUIT DRAIN PROBE AND Y ADAPTER 132 manufactured by Ballard Medical Products.

Event Text Entries

[17034528] Closed circuit drains were suctioned. Pt became bradycardic and hypotensive. Passive exhalation diaphragm was stuck preventing the pt from exhaling which caused over expansion of the lungs causing cardiac tamponade with subsequent bradycardia and hypotension.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1016857
• MDR Report Key: 234548
• Date Received: 1999-08-04
• Date of Report: 1999-07-29
• Date of Event: 1999-07-22
• Date Added to Maude: 1999-08-06
• 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: BALLARD CLOSED CIRCUIT DRAIN PROBE AND Y ADAPTER
• Generic Name: CLOSED CIRCUIT DRAIN, PROBE AND Y ADAPTER
• Product Code: BYH
• Date Received: 1999-08-04
• Model Number: NA
• Catalog Number: 132
• Lot Number: 65219
• ID Number: 4867153 (PATENTS)
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 227322
• Manufacturer: BALLARD MEDICAL PRODUCTS
• Manufacturer Address: 12050 LONE PEAK PKWY DRAPER UT 84020 US
• Baseline Brand Name: SAFETY DRAIN
• Baseline Generic Name: CLOSED CIRCUIT DRAIN
• Baseline Model No: NA
• Baseline Catalog No: 132
• Baseline ID: NA
• Baseline Device Family: CLOSED CIRCUIT DRAIN
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K881790
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	1999-08-04