PENCAN? 333851

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 2018-01-05 for PENCAN? 333851 manufactured by B. Braun Medical Inc..

Event Text Entries

[96952797] (b)(4). The device involved has not been received for evaluation and the investigation is ongoing at this time. A follow-up report will be submitted when the results of the investigation become available.
Patient Sequence No: 1, Text Type: N, H10


[96952798] As reported by user facility: event 2: during a spinal procedure, the introducer bent creating metal fragments. A second spinal kit was then opened and used. No known patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2523676-2017-00180
MDR Report Key7169060
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2018-01-05
Date of Report2018-01-05
Date of Event2017-12-11
Date Mfgr Received2017-12-12
Date Added to Maude2018-01-05
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 ContactJONATHAN 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 NamePENCAN?
Generic NameSPINAL ANESTHESIA KIT
Product CodeOFU
Date Received2018-01-05
Catalog Number333851
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerB. BRAUN MEDICAL INC.
Manufacturer Address901 MARCON BLVD ALLENTOWN PA 18109 US 18109


Patients

Patient NumberTreatmentOutcomeDate
10 2018-01-05

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