MALLINCKRODT 85864

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-04 for MALLINCKRODT 85864 manufactured by Mmj Sa De Cv(usd).

Event Text Entries

[104287434] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[104287435] According to the reporter, the anesthesiologist forwarded an email which states he believes this stylet part number 85864 is "too short and flimsy".
Patient Sequence No: 1, Text Type: D, B5


[117311591] Additional information: (udi). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[119996613] Correction: this device in this report is product code: bsr, device class: 1 regulation number: 868. 5790 (510k exempt). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[119996614] According to the reporter, the anesthesiologist forwarded an email which states he believes this stylet part number 85864 is "too short and flimsy". It was reported that this product is "inferior" due to not providing enough support and the outer covering being too slick. There was no injury reported associated with this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2018-00222
MDR Report Key7395788
Report SourceUSER FACILITY
Date Received2018-04-04
Date of Report2018-05-25
Date Mfgr Received2018-03-06
Date Added to Maude2018-04-04
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 FDA3
Event Location3
Manufacturer ContactAVI KLUGER
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone3035306582
Manufacturer G1MMJ SA DE CV(USD)
Manufacturer StreetAVE HENEQUEN NO 1181 DESARROL
Manufacturer CityCIUDAD JUAREZ 32590
Manufacturer CountryMX
Manufacturer Postal Code32590
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMALLINCKRODT
Generic NameSTYLET, TRACHEAL TUBE
Product CodeBSR
Date Received2018-04-04
Model Number85864
Catalog Number85864
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMMJ SA DE CV(USD)
Manufacturer AddressAVE HENEQUEN NO 1181 DESARROL CIUDAD JUAREZ 32590 MX 32590


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-04-04

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