Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN; MULTIPURPOSE CULTURE MEDIUM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON, DICKINSON & CO. BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN; MULTIPURPOSE CULTURE MEDIUM Back to Search Results
Catalog Number 221788
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/25/2019
Event Type  malfunction  
Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin, four occurrences of non-viable organisms in the media were observed.Results were erroneously reported based on gram stain.No information was available on how patient treatment was changed or if treatment was changed.No misdiagnosis or worsening in patient condition was indicated.
 
Event Description
It was reported that while using bd bbl¿ thioglycollate medium, enriched with vitamin k1 and hemin, four occurrences of non-viable organisms in the media were observed.Results were erroneously reported based on gram stain.No information was available on how patient treatment was changed or if treatment was changed.No misdiagnosis or worsening in patient condition was indicated.
 
Manufacturer Narrative
Investigation summary this product is manufactured by rehydrating the media components with usp purified water, and thoroughly mixing until a homogeneous solution is obtained.The tubes are filled, capped, torqued and then labeled by machine per standard operating procedure (sop).The tubes are terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, tubes are packaged into final shipping configurations.The batch history record review for batch 9234989 was satisfactory per internal procedures.Formulation, filling and autoclaving processes were within specifications.Qc inspection and testing were satisfactory at time of release.The release testing that is performed on this product does include review of its color and clarity.Samples submitted are examined to ensure that they conform to typical levels.The appearance of this batch was satisfactory per internal procedures.Direct staining techniques are not part of qc release testing for this product.Additionally as part of the release criteria for this product, the bhr is reviewed to confirm the following: --the total elapsed time between end of formulation and start of the autoclave cycle was within the specified limits.--all autoclave parameters conformed to the validated cycle parameters for this product.--the minimum f0 for this product was met.The complaint history was reviewed and other complaints have been taken on this batch for appearance but are also not confirmed.Retention samples from batch 9234989 were available for inspection.No cap, tube or media defects were observed in 10/10 retention tubes.The clarity specification for this product is clear to trace hazy and all retention samples were within specifications.No appearance defects or microbial growth were found in the retention samples.Returns were received for investigation.A total of 249 tubes from batch 9234989 in 100pack cartons were shipped in a box (cartons 0096, 0185, 0189).Twenty-five tubes from batch 9212952 in a 100pack carton (#0353) were returned in a box with bubble wrap.No cap, tube or media defects were observed in 249/249 returned tubes.In some return tubes, some fine sediment that settled at the bottom of the tube could be seen when the tube was inverted.But when that sediment was distributed throughout the media the sediment did not make the media appear more than trace hazy.No appearance defects or microbial growth were found in the return samples.There is no sterile claim on this product.Culture media sometimes contain dead organisms derived from medium constituents, which may be visible in smears of culture media.Other sources of dead organisms visible upon gram staining include staining reagents, immersion oil, glass slides, and the specimens used for inoculation.If there is uncertainty about the validity of the gram stain, the culture should be reincubated for another hour or two and the test repeated before a report is given.Bd will continue to trend complaints for contamination or non-viables.This complaint cannot be confirmed.Bd has confirmed the presence of non-viable organisms.However, bd cannot confirm this complaint as it is out of claims.This product does not have a specification for non-viable organisms.Due to the biological nature of the media nonviable organisms can be present.There are statements within the product insert that address the impact of nonviable organisms on the gram staining process in both the precautions and limitations of procedure sections.O "caution should be exercised in reporting direct gram stain and/or other direct microbiological stain results on tissue specimens processed with this medium due to the possible presence of nonviable organisms in the culture medium." o "culture media sometimes contain dead organisms derived from medium constituents, which may be visible in smears of culture media.Other sources of dead organisms visible upon gram staining include staining reagents, immersion oil, glass slides and the specimens used for inoculation.If there is uncertainty about the validity of the gram stain, the culture should be reincubated for another hour or two and the test repeated before a report is given.Bd has initiated capa# 1071036 which is in the investigation stage to determine what has caused the increase in non-viable organisms seen within this media.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD BBL¿ THIOGLYCOLLATE MEDIUM, ENRICHED WITH VITAMIN K1 AND HEMIN
Type of Device
MULTIPURPOSE CULTURE MEDIUM
Manufacturer (Section D)
BECTON, DICKINSON & CO.
250 schilling circle
cockeysville MD 21030
MDR Report Key9362627
MDR Text Key199912963
Report Number1111096-2019-00119
Device Sequence Number1
Product Code JSG
UDI-Device Identifier00382902217886
UDI-Public00382902217886
Combination Product (y/n)N
PMA/PMN Number
K803023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/14/2020
Device Catalogue Number221788
Device Lot Number9234989
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/31/2019
Initial Date FDA Received11/22/2019
Supplement Dates Manufacturer Received10/31/2019
Supplement Dates FDA Received05/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-