THIOGLYCOLLATE ENRICHED MEDIUM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-12-18 for THIOGLYCOLLATE ENRICHED MEDIUM manufactured by Becton Dickinson.

Event Text Entries

[21286869] Becton dickinson enriched thioglycollate medium was used at hospital, to disperse tissue for gram stain and to aliquote samples to various medias. Gram stains of multiple sequential tissue specimens were reported as positive for gram positive cocci. No growth was ever detected. Because not all bacteria seen on gram stain from clinical specimens grew due to a variety of circumstances including the possibility of fastidious organisms or patients receiving antibiotics prior to specimen collection, this problem was not immediately identified. Some patients had central venous catheters placed to facilitate a anticipated long term antibiotic administration. Only after several patients with no clinical suspicion for infection were identified with clinical specimens described as having positive gram stains but negative cultures was the non inoculated thioglycollate medium gram stained and cultured. Non viable gram positive cocci was consistently detected from multiple lots of becton dickinson enriched thioglycollate medium. While the hospital stopped dispersing tissue specimens in thioglycollate medium for gram stain, the presence of non viable gram positive cocci remains a potentially significant issue. Nutrient broth inoculated with turbid fluid or tissue will appear cloudy. After incubation, this cloudy appearance necessitates evaluation to determine if bacteria are present. Non viable gram positive cocci in the broth leads to further clinical problems. Dates of use: 2008. Diagnosis or reason for use: rule out infection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5009382
MDR Report Key1274722
Date Received2008-12-18
Date of Report2008-12-18
Date of Event2008-08-01
Date Added to Maude2009-01-09
Event Key0
Report Source CodeVoluntary 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 Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameTHIOGLYCOLLATE ENRICHED MEDIUM
Generic NameNONE
Product CodeJSC
Date Received2008-12-18
Lot Number8161157
Device Expiration Date2009-06-04
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON

Device Sequence Number: 2

Brand NameTHIOGLYCOLLATE ENRICHED MEDIUM
Generic NameNONE
Product CodeJSC
Date Received2008-12-18
Lot Number816093
Device Expiration Date2009-06-04
Device Sequence No2
Device Event Key0
ManufacturerBECTON DICKINSON

Device Sequence Number: 3

Brand NameTHIOGLYCOLLATE ENRICHED MEDIUM
Generic NameNONE
Product CodeJSC
Date Received2008-12-18
Lot Number8126154
Device Expiration Date2009-04-30
Device Sequence No3
Device Event Key0
ManufacturerBECTON DICKINSON


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-12-18

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