SHILEY 18870

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-09 for SHILEY 18870 manufactured by Mmj Sa De Cv (usd).

Event Text Entries

[182769244] Evaluation summary: one product's photos were received. The reported event was confirmed in the provided photos. Photos are provided for evaluation and it was observed the printing on the pouch describes a device (size 7. 0) and the tube inside the pouch is (size 7. 5). Capa (b)(4) was initiated to address the reported failure. The severity was assessed as 9 (hazardous - failure occurs with warning) - failure resulting in harm to user, patient, operator or environment which does not affect other system elements. Information has been added to the database and trends will continue to be monitored. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[182769248] According to the reporter, the device had wrong size was packaged. A packaged labeled as size 7. 0mm but size was 7. 5mm. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2936999-2020-00196
MDR Report Key9809039
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-09
Date of Report2020-03-09
Date of Event2020-02-08
Date Mfgr Received2020-02-14
Device Manufacturer Date2017-10-09
Date Added to Maude2020-03-09
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 Street5920 LONGBOW DRIVE
Manufacturer CityBOULDER CO 80301
Manufacturer CountryUS
Manufacturer Postal80301
Manufacturer Phone3035306582
Manufacturer G1MMJ SA DE CV (USD)
Manufacturer StreetAVE HENEQUEN NO 1181 DESARROLL
Manufacturer CityCIUDAD JUAREZ 32590
Manufacturer CountryMX
Manufacturer Postal Code32590
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSHILEY
Generic NameTUBE, TRACHEAL (W/WO CONNECTOR)
Product CodeBTR
Date Received2020-03-09
Returned To Mfg2020-03-09
Model Number18870
Catalog Number18870
Lot Number17J0265JZX
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMMJ SA DE CV (USD)
Manufacturer AddressAVE HENEQUEN NO 1181 DESARROLL CIUDAD JUAREZ 32590 MX 32590


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-09

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