INFLATOR SYRINGE 622510

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 2019-11-04 for INFLATOR SYRINGE 622510 manufactured by B. Braun Medical Inc..

MAUDE Entry Details

Report Number2523676-2019-00189
MDR Report Key9271299
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-11-04
Date of Report2019-11-04
Date of Event2019-10-03
Date Mfgr Received2019-10-08
Device Manufacturer Date2018-12-03
Date Added to Maude2019-11-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. JONATHAN SEVERINO
Manufacturer Street901 MARCON BLVD.
Manufacturer CityALLENTOWN PA 18109
Manufacturer CountryUS
Manufacturer Postal18109
Manufacturer Phone4847197287
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINFLATOR SYRINGE
Generic NameINJECTOR AND SYRINGE, ANGI
Product CodeDXT
Date Received2019-11-04
Catalog Number622510
Lot Number0061649903
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MEDICAL INC.
Manufacturer Address901 MARCON BLVD. ALLENTOWN PA 18109 US 18109


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-04

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