PORTEX PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS 482802-NL

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 2020-03-01 for PORTEX PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS 482802-NL manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[181656366] Information was received that during the use of a smiths medical portex pediatric disposable anesthesia breathing circuits the bag detached from black cap and was unable to continue use. Bag replaced with new on and ventilation was continued. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2020-01631
MDR Report Key9772856
Report SourceUSER FACILITY
Date Received2020-03-01
Date of Report2020-03-01
Date Mfgr Received2020-01-31
Device Manufacturer Date2018-12-21
Date Added to Maude2020-03-01
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 ContactDAVE HALVERSON
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS, MN
Manufacturer CountryUS
Manufacturer G1SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
Manufacturer StreetAVE CALIDAD NO. 4, PARQUE INDUSTRIALINTERNACIONAL
Manufacturer CityTIJUANA, 22425
Manufacturer CountryMX
Manufacturer Postal Code22425
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX PEDIATRIC DISPOSABLE ANESTHESIA BREATHING CIRCUITS
Generic NameANESTHESIA BREATHING CIRCUIT KIT (ADULT & PEDIATRIC) PRODUCT CODE: OFP
Product CodeOFP
Date Received2020-03-01
Model Number482802-NL
Lot Number3739563
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS, MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-01

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