BBL MYCOBACTERIA GROWTH INDICATOR 7ML TUBE 245122 (FORMERLY 4345122)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2001-05-11 for BBL MYCOBACTERIA GROWTH INDICATOR 7ML TUBE 245122 (FORMERLY 4345122) manufactured by Bd Diagnostic Systems.

Event Text Entries

[21713709] An innoculated tube leaked 1-2 ml of liquid into the instrument. Four weeks after the incident the specimen is negative for mycobacteria along with two other samples ffrom the same patient. Only a streptococcus spp. Was isolated. No death or serious injury has ocurred as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1119779-2001-00003
MDR Report Key333118
Report Source01,06,07
Date Received2001-05-11
Date of Report2001-05-11
Date of Event2001-04-12
Date Mfgr Received2001-04-12
Device Manufacturer Date2000-09-01
Date Added to Maude2001-05-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 Location0
Manufacturer ContactDAVID GATES
Manufacturer Street7 LOVETON CIRCLE
Manufacturer CitySPARKS MD 21152
Manufacturer CountryUS
Manufacturer Postal21152
Manufacturer Phone4103164367
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBBL MYCOBACTERIA GROWTH INDICATOR 7ML TUBE
Generic NameCULTURE MEDIA
Product CodeJSC
Date Received2001-05-11
Model NumberNA
Catalog Number245122 (FORMERLY 4345122)
Lot Number0258228
ID Number*
Device Expiration Date2001-10-01
OperatorUNKNOWN
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key322492
ManufacturerBD DIAGNOSTIC SYSTEMS
Manufacturer Address7 LOVETON CIR. SPARKS MD 21152 US
Baseline Brand NameBBL MYCOBACTERIA GROWTH INDICATOR 7ML TUBE
Baseline Generic NameCLUTURE MEDIA
Baseline Model NoNA
Baseline Catalog No245122 (FORMERLY 4345122)
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2001-05-11

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