DARBY PRIVATE LABEL NEEDLE 30GA SHORT 03N1301

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-30 for DARBY PRIVATE LABEL NEEDLE 30GA SHORT 03N1301 manufactured by Sofic Sas.

MAUDE Entry Details

Report Number0001721729-2019-00003
MDR Report Key9255028
Date Received2019-10-30
Date of Report2019-10-30
Date Facility Aware2019-02-12
Report Date2019-10-01
Date Reported to Mfgr2019-10-01
Date Added to Maude2019-10-30
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDARBY PRIVATE LABEL NEEDLE 30GA SHORT
Generic NameDARBY PRIVATE LABEL NEEDLE
Product CodeDZM
Date Received2019-10-30
Catalog Number03N1301
Lot NumberF08243AA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSOFIC SAS
Manufacturer Address3, RUE JEAN-JACQUES ROUSSEAU AUSSILLON MAZAMET CEDEX, 81207 FR 81207


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-10-30

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