INFLATABLE TRACHEAL TUBE CUFF 8199

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-11-07 for INFLATABLE TRACHEAL TUBE CUFF 8199 manufactured by J. T. Posey Co..

Event Text Entries

[17977374] Customer reported that the needle will not rest at zero when pressure is released. There was no patient incident or injury reported.
Patient Sequence No: 1, Text Type: D, B5


[18245820] Results - evaluation of the returned product confirmed the reported issue that the needle will not rest at zero when pressure is released. The needle pointer is at 24, but moves up when the inflation bulb is squeezed and holds pressure. When the pressure is released the needle returns to 24. No readings were taken due to the position of the needle. Visual findings revealed the perflex face plate is chipped, rubber protective ring is missing, and needle is bent. Note: instructions for use indicates: inspect the unit and check the cuff for leaks prior to use. Prior to intubation or extubation, withdraw all the air from the cuff with a syringe and close the inflation line. The cufflator should be calibrated annually, or if the measurements fall outside of the range, or if the needle does not indicate a pressure reading of zero when nothing is connected, or if the unit is ever dropped. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2020362-2012-00635
MDR Report Key2865306
Report Source08
Date Received2012-11-07
Date of Report2012-10-10
Date Mfgr Received2012-10-10
Date Added to Maude2013-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMARY SEGURA
Manufacturer Street5635 PECK RD.
Manufacturer CityARCADIA CA 91006
Manufacturer CountryUS
Manufacturer Postal91006
Manufacturer Phone6264433143
Manufacturer G1J. T. POSEY CO.
Manufacturer Street5635 PECK RD.
Manufacturer CityARCADIA CA 91006
Manufacturer CountryUS
Manufacturer Postal Code91006
Single Use3
Previous Use Code3
Removal Correction NumberNA
Event Type3
Type of Report3

Device Details

Brand NameINFLATABLE TRACHEAL TUBE CUFF
Product CodeBSK
Date Received2012-11-07
Returned To Mfg2012-10-16
Model Number8199
Catalog Number8199
Lot Number1015133
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerJ. T. POSEY CO.
Manufacturer AddressARCADIA CA US


Patients

Patient NumberTreatmentOutcomeDate
10 2012-11-07

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