SMARTIP MED-PREP CANNULA 8881540111

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-10-17 for SMARTIP MED-PREP CANNULA 8881540111 manufactured by Covidien.

Event Text Entries

[164434459] An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10


[164434460] The customer reported they found 3 blunt tip cannulas with mold inside.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1017768-2019-00697
MDR Report Key9202140
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2019-10-17
Date of Report2019-10-17
Date of Event2019-10-07
Date Mfgr Received2019-10-07
Date Added to Maude2019-10-17
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 ContactJILL SARAIVA
Manufacturer Street15 HAMPSHIRE STREET
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal02048
Manufacturer Phone5086172514
Manufacturer G1COVIDIEN
Manufacturer Street2010 EAST INTERNATIONAL SPEEDW
Manufacturer CityDELAND FL 32724
Manufacturer CountryUS
Manufacturer Postal Code32724
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMARTIP MED-PREP CANNULA
Generic NameCANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
Product CodeGEA
Date Received2019-10-17
Model Number8881540111
Catalog Number8881540111
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN
Manufacturer Address2010 EAST INTERNATIONAL SPEEDW DELAND FL 32724 US 32724


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-17

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