DRAINAGE BAG UNK 72110511

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-18 for DRAINAGE BAG UNK 72110511 manufactured by B Braun Medical, Inc.

Event Text Entries

[21704757] Drainage bag ruptured when bag gets filled to a certain level. Drainage runs all over the floor and drain amount accuracy is not known any longer due to rupture.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number812212
MDR Report Key812212
Date Received2007-01-18
Date of Report2007-01-12
Date of Event2006-12-21
Report Date2007-01-12
Date Reported to FDA2007-01-18
Date Added to Maude2007-02-06
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameDRAINAGE BAG
Generic NameBAG, DRAINAGE
Product CodeFIF
Date Received2007-01-18
Returned To Mfg2007-01-02
Model NumberUNK
Catalog Number72110511
Lot Number061124
ID Number*
Device AvailabilityR
Device Age1 DY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key799695
ManufacturerB BRAUN MEDICAL, INC
Manufacturer AddressMANUFACTURING DIVISION 901 MARCON BOULEVARD ALLENTOWN PA 18109 US


Patients

Patient NumberTreatmentOutcomeDate
10 2007-01-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.