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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) PLATE THAYER-MARTIN SELECTIVE AGAR

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BECTON, DICKINSON & CO. (SPARKS) PLATE THAYER-MARTIN SELECTIVE AGAR Back to Search Results
Catalog Number 251184
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2021
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 while using plate thayer-martin selective agar there was a failure to inhibit proteus.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# was sent in error.This material # is an luo (laboratory use only) and does not meet the criteria of a medical device as stated in 21 cfr 803.Therefore, this complaint is not mdr reportable.
 
Event Description
It was reported while using plate thayer-martin selective agar there was a failure to inhibit proteus.
 
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Brand Name
PLATE THAYER-MARTIN SELECTIVE AGAR
Type of Device
NA
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
MDR Report Key11244773
MDR Text Key230246949
Report Number1119779-2021-00157
Device Sequence Number1
Product Code JTY
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 06/30/2021
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 Date01/18/2021
Device Catalogue Number251184
Device Lot Number0268186
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/07/2021
Initial Date FDA Received01/28/2021
Supplement Dates Manufacturer Received07/12/2021
Supplement Dates FDA Received07/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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