MALLINCKRODT 109-70

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-14 for MALLINCKRODT 109-70 manufactured by Mallinckrodt Medical.

Event Text Entries

[129436684] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[129436685] According to the reporter, the tube disconnected from the patient due to separation of the tube connector from the actual tube in the patient's throat. The customer reported that the patient had connector disconnected from the tube a few times during the shift. That patient was extubated.
Patient Sequence No: 1, Text Type: D, B5


[133094465] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[133094466] According to the reporter, the et tube disconnected from patient due to separation of the et tube connector from the actual tube in patient's throat. The customer reported that patient had connector disconnect from the tube a few times during the shift. Patient death was not related to the device malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8020889-2018-00134
MDR Report Key8128498
Date Received2018-11-14
Date of Report2018-11-07
Date of Event2018-11-07
Date Mfgr Received2018-12-14
Date Added to Maude2018-12-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAVI KLUGER
Manufacturer Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone3035306582
Manufacturer G1MALLINCKRODT MEDICAL
Manufacturer StreetCORNAMADDY
Manufacturer CityATHLONE 03810
Manufacturer Postal Code03810
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMALLINCKRODT
Product CodeBSK
Date Received2018-11-14
Model Number109-70
Catalog Number109-70
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMALLINCKRODT MEDICAL
Manufacturer AddressCORNAMADDY ATHLONE 03810 03810


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2018-11-14

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