B.BRAUN 332100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-05-15 for B.BRAUN 332100 manufactured by B. Braun Medical Inc..

Event Text Entries

[145134937] (b)(4). The device involved has not been received for evaluation and the investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
Patient Sequence No: 1, Text Type: N, H10


[145134938] As reported by the user facility: the customer opened a tray and the syringe had a liquid substance inside that smeared when the plunger was moved. No injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523676-2019-00061
MDR Report Key8612022
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2019-05-15
Date of Report2019-06-29
Date Mfgr Received2019-05-02
Device Manufacturer Date2018-09-19
Date Added to Maude2019-05-15
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 Street861 MARCON BOULEVARD
Manufacturer CityALLENTOWN PA 18109
Manufacturer CountryUS
Manufacturer Postal18109
Manufacturer Phone4842408332
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameB.BRAUN
Generic NameNERVE BLOCK TRAY (KIT)
Product CodeOGJ
Date Received2019-05-15
Returned To Mfg2019-06-13
Catalog Number332100
Lot Number0061637305
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MEDICAL INC.
Manufacturer Address901 MARCON BLVD ALLENTOWN 18109 US 18109


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-15

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