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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD BBL¿ TRYPTICASE¿ SOY BROTH; MULTIPURPOSE CULTURE MEDIUM
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BECTON, DICKINSON & CO. BD BBL¿ TRYPTICASE¿ SOY BROTH; MULTIPURPOSE CULTURE MEDIUM Back to Search Results
Catalog Number 221093
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/03/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that while using bd bbl¿ trypticase¿ soy broth the customer alleged that the media was defective and was causing non-specific issues with culturing and processing tissues.The customer indicated the use of the media resulted in discrepant results and loss of donor tissue.No information was available on how the patient treatment was changed or if treatment was changed.No misdiagnosis or worsening in patient condition was indicated.Three attempts were made to follow-up for additional information without a response.
 
Event Description
It was reported that while using bd bbl¿ trypticase¿ soy broth the customer alleged that the media was defective and was causing non-specific issues with culturing and processing tissues.The customer indicated the use of the media resulted in discrepant results and loss of donor tissue.No information was available on how the patient treatment was changed or if treatment was changed.No misdiagnosis or worsening in patient condition was indicated.Three attempts were made to follow-up for additional information without a response.
 
Manufacturer Narrative
H.6.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 9051900 was satisfactory and no notifications were generated during manufacturing and inspection.Formulation, filling and autoclave processes were within specifications.Qc inspection and testing were satisfactory at time of release.Please note that direct staining techniques are not part of qc release testing for this product as non-viable organisms may be present in the media.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.The complaint history was reviewed and no other complaints have been taken for performance but this customer does have another complaint for clarity.Retention samples from batch 9051900 (10 tubes) were available for inspection.No cap, tube or media defects were observed in the retention samples.The clarity specification for this product is clear to trace hazy.The retention samples were satisfactory for appearance.Returns were received for investigation.One hundred tubes from batch 9051900 were returned in a 100pack carton (#312) in an insulated box with ice packs and air bubbles.No cap, tube or media defects were observed in 100/100 returned tubes.For investigation of this complaint, return and retention tubes were tested as described in the certificate of analysis and all organisms had growth within the specified time as expected.No performance defects were observed in the returns and retention samples tested.Bd will continue to trend complaints for performance.This complaint cannot be confirmed.Root cause is undetermined, could not replicate performance failure.Based on batch trend data for this defect, no corrective action is indicated at this time.
 
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Brand Name
BD BBL¿ TRYPTICASE¿ SOY BROTH
Type of Device
MULTIPURPOSE CULTURE MEDIUM
Manufacturer (Section D)
BECTON, DICKINSON & CO.
250 schilling circle
cockeysville MD 21030
MDR Report Key8851314
MDR Text Key155853308
Report Number1111096-2019-00108
Device Sequence Number1
Product Code JSG
UDI-Device Identifier00382902210931
UDI-Public00382902210931
Combination Product (y/n)N
PMA/PMN Number
PREAMEND.
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/15/2020
Device Catalogue Number221093
Device Lot Number9051900
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/05/2019
Initial Date FDA Received08/01/2019
Supplement Dates Manufacturer Received07/05/2019
Supplement Dates FDA Received01/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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