ENDOTRACHEAL TUBE SIZE 7.0 43156-070

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for ENDOTRACHEAL TUBE SIZE 7.0 43156-070 manufactured by Baxter Healthcare Corp.

Event Text Entries

[4822] Patient already restrained when patient extubated herself. Balloon on tube was found to be partially deflated. Patient was sedated and intubated for a seconc time and again the balloon was deflated causing the patient to extubate herself. Stress and trauma of intubation was following result. 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: visual examination. Results of evaluation: pilot balloon valve. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6786
MDR Report Key6786
Date Received1993-07-22
Date of Report1993-02-17
Date of Event1993-01-28
Date Facility Aware1993-01-28
Report Date1993-02-17
Date Reported to Mfgr1993-02-16
Date Added to Maude1993-10-15
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameENDOTRACHEAL TUBE SIZE 7.0
Product CodeLNZ
Date Received1993-07-22
Catalog Number43156-070
Lot NumberNA
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagY
Device Sequence No1
Device Event Key6469
ManufacturerBAXTER HEALTHCARE CORP


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1993-07-22

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