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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING
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BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING Back to Search Results
Model Number 442023
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/04/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: no event occurrence date is listed; used awareness date from global complaint a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic) for validation, the customer has failed twice to recover neisseria meningitidis.Even after adding fos supplement.In addition, even with the new approach neisseria has not grown in the aerobic bottle, but has grown in the pet bottle.No patient impact was reported.The following information was provided by the initial reporter: the customer is stating that during validation they have failed twice when trying to recover neisseria meningitidis.Even after adding fos supplement.Even with a new approach, the neisseries have not grown in the aerobic bottle.The same neiss.Has grown in the pet bottle.
 
Event Description
It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic) for validation, the customer has failed twice to recover neisseria meningitidis.Even after adding fos supplement.In addition, even with the new approach neisseria has not grown in the aerobic bottle, but has grown in the pet bottle.No patient impact was reported.The following information was provided by the initial reporter: the customer is stating that during validation they have failed twice when trying to recover neisseria meningitidis.Even after adding fos supplement.Even with a new approach, the neisseries have not grown in the aerobic bottle.The same neiss.Has grown in the pet bottle.
 
Manufacturer Narrative
H6: investigation summary: satisfactory results were obtained from retention samples when tested for microbial instrument detection.Also, gram stain was performed with satisfactory results.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.Batch and sensor history records review did not identify any evidence for which the customer submitted the complaint.Complaint is unconfirmed based on retention samples and batch record review results.Quality control certificates list test organism, including atcc¿ culture specified in the clsi standard m22, quality control for commercially prepared microbiological culture media for expected atcc performance.
 
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Brand Name
BD BACTEC¿ PLUS AEROBIC/F CULTURE VIALS (PLASTIC)
Type of Device
SYSTEM, BLOOD CULTURING
Manufacturer (Section D)
BECTON DICKINSON CARIBE LTD.
vicks drive
lot no. 6
cayey PR
Manufacturer (Section G)
BECTON DICKINSON CARIBE LTD.
vicks drive
lot no. 6
cayey PR
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15621619
MDR Text Key307078108
Report Number2647876-2022-00219
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904420239
UDI-Public00382904420239
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K113558
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 11/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date01/31/2023
Device Model Number442023
Device Catalogue Number442023
Device Lot Number2088604
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2022
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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