PENCAN? 333868

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-06 for PENCAN? 333868 manufactured by B. Braun Medical Inc..

Event Text Entries

[182935239] This report has been identified as b. Braun medical internal report number (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


[182935240] As reported by the user facility: it was reported that dirt was seen on the syringe. No injury reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523676-2020-00056
MDR Report Key9800824
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-06
Date of Report2020-03-06
Date Mfgr Received2020-02-21
Device Manufacturer Date2019-10-15
Date Added to Maude2020-03-06
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
Manufacturer CountryUS
Manufacturer Phone7197287
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePENCAN?
Generic NameSPINAL ANESTHESIA KIT
Product CodeOFU
Date Received2020-03-06
Model Number333868
Catalog Number333868
Lot Number0061695820
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MEDICAL INC.
Manufacturer Address901 MARCON BLVD. ALLENTOWN, PA US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-06

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