DENNIS TUBE 8888-268011 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-04 for DENNIS TUBE 8888-268011 UNKNOWN manufactured by Argyle.

Event Text Entries

[19233911] Upon x-ray dennis tube found to be in lung. While removing the dennis tube, balloon with mercury broke and spilled into lungs. Upon investigation balloon found to have a tear approximately. 5mm in length. Prior to incident patient in cricital condition with do not resuscitate orders. Serial chest x-rays done which confirmed mercury in lungs. Patient expired three (3) days after event occurred. It cannot be determined whether event contributed to death because patient was in critical condition prior to event and autopsy was refused. Device labeled for single use. Patient medical status prior to event: critical condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: component failure, incorrect technique/procedure, balloon. Conclusion: device failure directly contributed to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: user education provided. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3717
• MDR Report Key: 3717
• Date Received: 1992-08-04
• Date of Report: 1992-05-13
• Date of Event: 1992-04-30
• Date Facility Aware: 1992-04-30
• Report Date: 1992-05-13
• Date Reported to FDA: 1992-05-13
• Date Reported to Mfgr: 1992-05-13
• Date Added to Maude: 1993-05-03
• 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: 0
• Initial Report to FDA: 0
• 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: DENNIS TUBE
• Product Code: FEF
• Date Received: 1992-08-04
• Model Number: 8888-268011
• Catalog Number: UNKNOWN
• Lot Number: 443031 A
• ID Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3463
• Manufacturer: ARGYLE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1992-08-04