SAFEDRAW BLOOD SAMPLING SYSTEM 688396/B

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-15 for SAFEDRAW BLOOD SAMPLING SYSTEM 688396/B manufactured by Merit Medical Singapore Pte Ltd..

MAUDE Entry Details

Report Number8020616-2020-00003
MDR Report Key9594322
Report SourceCOMPANY REPRESENTATIVE,DISTRI
Date Received2020-01-15
Date of Report2019-12-16
Date of Event2019-12-02
Date Mfgr Received2020-02-12
Device Manufacturer Date2019-06-23
Date Added to Maude2020-01-15
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 ContactMR. DAVID LOCKRIDGE
Manufacturer Street1600 MERIT PARKWAY
Manufacturer CitySOUTH JORDAN UT 84095
Manufacturer CountryUS
Manufacturer Postal84095
Manufacturer Phone8012084551
Manufacturer G1MERIT MEDICAL SINGAPORE PTE LTD.
Manufacturer Street198 YISHUN AVE 7
Manufacturer CitySINGAPORE, 768926
Manufacturer CountrySN
Manufacturer Postal Code768926
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSAFEDRAW BLOOD SAMPLING SYSTEM
Generic NameBLOOD SAMPLING SYSTEM
Product CodeDXN
Date Received2020-01-15
Catalog Number688396/B
Lot NumberC1581267
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMERIT MEDICAL SINGAPORE PTE LTD.
Manufacturer Address198 YISHUN AVE 7 SINGAPORE, 768926 SN 768926


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-15

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