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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 False Positive Result (1227)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
Event Type  malfunction  
Event Description
It was reported that while testing with the bd bactec¿ plus aerobic/f culture vials (plastic), a false positive result was obtained.Confirmatory gram testing was performed and the result was negative.Erroneous results were not reported out and there was no patient impact.The following information was provided by the initial reporter: false positive due to blood under the sensor at the bottom of the vial.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: customer reported sensor adhesion defect and a false positive result.Two out of three photos received showed a sensor adhesion defect.Bd was unable to duplicate customer¿s experience with the bactec product.Retention samples were visually inspected with satisfactory results.Batch/sensor history records were reviewed, and all testing were within specification for product release.Blood background was performed with satisfactory results.A complaint history review was conducted and batch has been previously investigated for the reported defect.No additional testing is required at this time.Sensor adhesion scrape test is performed to each sensor batch as part of release criteria.Complaint is confirmed based on photos received.The vision system is challenged prior each lot.Product insert warnings and precautions sections states that prior to use, each vial should be examined for evidence of contamination such as cloudiness, bulging or depresses septum, or leakage.Vials showing evidence of contamination should not be used.Also prior to use, the user should examine the vial for evidence of damage or deterioration.Vials displaying turbidity, contamination, or discoloration (darkening) should not be used.Corrective actions preventive actions (capa) 2882676 was initiated to further investigate these types of complaints and determine any appropriate actions to reduce their occurrence.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.
 
Event Description
It was reported that while testing with the bd bactec¿ plus aerobic/f culture vials (plastic), a false positive result was obtained.Confirmatory gram testing was performed and the result was negative.Erroneous results were not reported out and there was no patient impact.The following information was provided by the initial reporter: false positive due to blood under the sensor at the bottom of the vial.
 
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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 Key13022044
MDR Text Key289112498
Report Number2647876-2021-00362
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904420239
UDI-Public00382904420239
Combination Product (y/n)N
Reporter Country CodeFR
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 12/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2022
Device Model Number442023
Device Catalogue Number442023
Device Lot Number1174481
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2021
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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