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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL STERILE PACK PLATED MEDIA
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BECTON, DICKINSON & CO. (SPARKS) BD BBL STERILE PACK PLATED MEDIA Back to Search Results
Catalog Number 292341
Device Problem Device Markings/Labelling Problem (2911)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2021
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.(b)(4).
 
Event Description
It was reported that no label or missing label information was found while using the bd bbl¿ sterile pack plated media.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that some plates are not stamped.
 
Manufacturer Narrative
H6: investigation summary: the batch history record review for batch 0245449 was satisfactory per internal procedures.The release testing that is performed on this product does include physical attribute testing.A sample of plates are tested for physical attributes prior to release to ensure that they conform to product specifications.All physical attribute testing performed on this batch was satisfactory per bd internal procedures.The complaint history was reviewed, and the only complaints on batch 0245449 were taken from this customer for different defects.Retention samples from batch 0245449 were available for inspection.Fifty plates in five unopened sleeves from batch 0245449 were inspected and 0/50 plates were broken, 0/50 plates had missing or illegible plate print and 5/50 plates had one single large bubble on the agar surface (time stamps 1435-1437).Two photos were received for complaint (b)(4) for missing plate print.One photo shows a sleeve label from batch 0245449 for batch verification.The other photo shows the bottom of an agar plate without a plate print on the bottom.No returns were received for investigation.This complaint can be confirmed for missing plate print by the photos provided.Bd will continue to trend complaints for missing plate print.Based on the low defect rate for this batch, no actions are planned at this time.
 
Event Description
It was reported that no label or missing label information was found while using the bd bbl¿ sterile pack plated media.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that some plates are not stamped.
 
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Brand Name
BD BBL STERILE PACK PLATED MEDIA
Type of Device
NA
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
MDR Report Key11229826
MDR Text Key229857630
Report Number1119779-2021-00142
Device Sequence Number1
Product Code JSE
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/03/2021
Device Catalogue Number292341
Device Lot Number0245449
Was Device Available for Evaluation? No
Date Manufacturer Received09/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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