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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD BBL¿ CAMPYLOBACTER AGAR PLATE SB; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL
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BECTON DICKINSON DE MEXICO BD BBL¿ CAMPYLOBACTER AGAR PLATE SB; CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL Back to Search Results
Catalog Number 217250
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/13/2022
Event Type  malfunction  
Event Description
It was reported that 2 bd bbl¿ campylobacter agar plates sb failed to inhibit the enterobacteriaceae.There was no indication of confirmatory testing, or that results were reported to clinicians.There was also no report of patient impact.The following information was provided by the initial reporter, translated from spanish: "lack of inhibition of enterobacteriaceae.2 bags with 10 plates each were received.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
After additional review, this mfr report was submitted in error.This is not a reportable event.This mdr should be considered canceled.
 
Event Description
It was reported that 2 bd bbl¿ campylobacter agar plates sb failed to inhibit the enterobacteriaceae.There was no indication of confirmatory testing, or that results were reported to clinicians.There was also no report of patient impact.The following information was provided by the initial reporter, translated from spanish: "lack of inhibition of enterobacteriaceae.2 bags with 10 plates each were received.".
 
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Brand Name
BD BBL¿ CAMPYLOBACTER AGAR PLATE SB
Type of Device
CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer (Section G)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14648520
MDR Text Key302071426
Report Number9614033-2022-00050
Device Sequence Number1
Product Code JSJ
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
K800541
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/19/2022
Device Catalogue Number217250
Device Lot Number2083771
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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