MINNESOTA FOUR LUMEN TUBE 9222 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-24 for MINNESOTA FOUR LUMEN TUBE 9222 UNKNOWN manufactured by Bard - Davol Inc..

Event Text Entries

[2369] Patient was to have a blakemore tube inserted for gi bleeding. The tube was inserted and then the patient was intubated with et tube and the blakemore tube came displaced and was removed. The blakemore tube was then re-inserted. At that time, it was noted that the gastric balloon did not inflate. The m. D. Noted that the tube and balloon had been checked prior to the usage of it. The tube was removed and no insufflation of the balloon occurred. The patient was then prepared for immediate surgery. The bleeding was not able to be controlled even with surgical intervention and the patient several hours after surgery in the critical care area. The tube was not retained for evaluation. Device not 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. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: device unavailable for follow-up investigation examination. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3091
• MDR Report Key: 3091
• Date Received: 1992-07-24
• Date of Report: 1992-01-17
• Date of Event: 1991-12-25
• Date Facility Aware: 1991-12-25
• Report Date: 1992-01-17
• Date Added to Maude: 1993-04-06
• 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: MINNESOTA FOUR LUMEN TUBE
• Generic Name: UNKNOWN
• Product Code: FEF
• Date Received: 1992-07-24
• Model Number: 9222
• Catalog Number: UNKNOWN
• Lot Number: UNKNOWN
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2892
• Manufacturer: BARD - DAVOL INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-24