SHERIDAN ENDO-TRACHEAL TUBE 7.5, 8.0 SIZES 10315 (SIZE 7.5) 10316 SIZE 8 5-10315

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-02-19 for SHERIDAN ENDO-TRACHEAL TUBE 7.5, 8.0 SIZES 10315 (SIZE 7.5) 10316 SIZE 8 5-10315 manufactured by Sheridan.

Event Text Entries

[15447727] Patient # 1. Developed leakage around e-t tube; r. T. Staff found that e-t tube fluctuated with cuff inflated. Pt. Vomited and aspirated possibly due to cuff moving upward at tip of trachea. Tube changed. Patient 2. Age 73 male critical prior to event - e-t tube appeared to move after insertation. Lung secretions suctioned dfrom mouth. Patient 3. Age 71 male critical prior to event - e-t tube changed x 1 in e-r; three days after admission, staff unable to suction through tube despite repeated attempts. E-t tube changed next day. Cuff had 70cc of air in upon removaldevice labeled for single use. Patient medical status prior to event: critical condition. There was multiple patient involvement. Number of patients involved: 3. 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: a device from same lot was evaluated, mechanical tests performed, visual examination. 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: device temporarily removed from service, invalid data. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 301
• MDR Report Key: 301
• Date Received: 1992-02-19
• Date of Report: 1992-01-31
• Date of Event: 1992-01-17
• Date Facility Aware: 1992-01-20
• Report Date: 1992-01-31
• Date Reported to FDA: 1992-01-31
• Date Reported to Mfgr: 1992-01-20
• Date Added to Maude: 1992-04-15
• 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: SHERIDAN ENDO-TRACHEAL TUBE 7.5, 8.0 SIZES
• Generic Name: E-T TUBE
• Product Code: LNZ
• Date Received: 1992-02-19
• Model Number: 10315 (SIZE 7.5) 10316 SIZE 8
• Catalog Number: 5-10315
• Lot Number: 9101G000057
• ID Number: NA
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 296
• Manufacturer: SHERIDAN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-02-19