ENDOTRACHEAL TUBE 43156-XXX

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 43156-XXX manufactured by Mallinkrodt Medical.

Event Text Entries

[3587] Patient extubated herself balloon on tube found to be deflated, patient had to be reintubated. Dept discarded tube, third occurance with this product. 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. Invalid data - regarding evaluation by user after event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number6789
MDR Report Key6789
Date Received1993-07-22
Date of Report1993-04-16
Date of Event1993-03-10
Date Facility Aware1993-03-10
Report Date1993-04-16
Date Reported to Mfgr1993-04-16
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
Product CodeLNZ
Date Received1993-07-22
Catalog Number43156-XXX
Lot NumberNA
Device AvailabilityN
Implant FlagY
Device Sequence No1
Device Event Key6472
ManufacturerMALLINKRODT MEDICAL


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1993-07-22

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