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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING
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BECTON DICKINSON CARIBE LTD. BD BACTEC¿ LYTIC/10 ANAEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING Back to Search Results
Catalog Number 442021
Device Problem False Positive Result (1227)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/30/2023
Event Type  malfunction  
Event Description
It was reported that during use with the bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) a molecular false positive result was obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer reported biofire false positive for c.Tropicalis.
 
Manufacturer Narrative
D4.Medical device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H4.Device manufacture date: unknown.
 
Event Description
It was reported that during use with the bd bactec¿ plus aerobic/f culture vials (plastic), a molecular false positive result for c.Tropicalis was obtained.The patient was treated with antifungals.The following information was provided by the initial reporter: biofire false positive for c.Tropicalis.#1 ¿ this pt had candida albicans as well so got antifungals.
 
Manufacturer Narrative
The following fields were updated: b1.Adverse type: reported issue is both an adverse event and product problem event attributed to: required intervention.B5.It was reported that during use with the bd bactec¿ plus aerobic/f culture vials (plastic), a molecular false positive result for c.Tropicalis was obtained.The patient was treated with antifungals.The following information was provided by the initial reporter: biofire false positive for c.Tropicalis.#1 ¿ this pt had candida albicans as well so got antifungals.H1.Type of reportable events: serious injury.H6.Health effect - clinical code.E2403 no clinical signs, symptoms, or conditions.Health effect - impact code.F23 unexpected medical intervention.
 
Manufacturer Narrative
Additional information was received which indicated the previously reported failure did not occur with this device.This mdr should be considered canceled.
 
Event Description
It was reported that during use with the bd bactec¿ lytic/10 anaerobic/f culture vials (plastic) a molecular false positive result was obtained.There was no report of patient impact.The following information was provided by the initial reporter: customer reported biofire false positive for c.Tropicalis.
 
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Brand Name
BD BACTEC¿ LYTIC/10 ANAEROBIC/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
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17935944
MDR Text Key325844793
Report Number3008352382-2023-00202
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904420215
UDI-Public00382904420215
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123903
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number442021
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/15/2023
Initial Date FDA Received10/13/2023
Supplement Dates Manufacturer Received10/16/2023
11/06/2023
Supplement Dates FDA Received10/31/2023
12/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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