PORTEX ANESTHESIA CIRCUIT CA13E0/400/000JP?

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 2019-05-12 for PORTEX ANESTHESIA CIRCUIT CA13E0/400/000JP? manufactured by Smiths Medical Asd, Inc..

Event Text Entries

[144810457] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[144810458] Information was received that a smiths medical portex anesthesia circuit set had a tear in the anesthesia bag during use. The issue was not detected during the pre-use check. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3012307300-2019-02639
MDR Report Key8602513
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-05-12
Date of Report2019-05-12
Date of Event2019-04-11
Date Mfgr Received2019-04-12
Device Manufacturer Date2018-12-07
Date Added to Maude2019-05-12
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 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer G1SMITHS MEDICAL ASD, INC
Manufacturer Street6000 NATHAN LANE NORTH
Manufacturer CityMINNEAPOLIS MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORTEX ANESTHESIA CIRCUIT
Generic NameCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) PRODUCT CODE: CAI
Product CodeCAI
Date Received2019-05-12
Returned To Mfg2019-04-16
Catalog NumberCA13E0/400/000JP?
Lot Number3732165
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL ASD, INC.
Manufacturer Address6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.