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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
Catalog Number 442023
Device Problem False Positive Result (1227)
Patient Problem Insufficient Information (4580)
Event Date 08/13/2023
Event Type  malfunction  
Event Description
Report 1 of 5 it was reported that bd bactec¿ plus aerobic/f culture vials (plastic) candida tropicalis false positive occurred.The following information was provided by the initial reporter: bactec 442023 molecular false positive what results were reported to clinicians and was patient treatment affected in response? in two cases, candida tropicalis was reported, the other three cases, candida tropicalis result was not reported.What organisms were seen on gram stain? gram positive cocci, yeast (with no growth of c.Tropicalis.C parapsilosis grew in this case); gnr.What organisms grew on culture plate? strep pneumoniae, candida parapsilosis, staph epidermidis, serratia marcescens.
 
Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
Report 1 of 5.It was reported that bd bactec¿ plus aerobic/f culture vials (plastic) candida tropicalis false positive occurred.The following information was provided by the initial reporter: bactec 442023 molecular false positive.What results were reported to clinicians and was patient treatment affected in response? in two cases, candida tropicalis was reported, the other three cases, candida tropicalis result was not reported.What organisms were seen on gram stain? gram positive cocci, yeast (with no growth of c.Tropicalis.C parapsilosis grew in this case); gnr.What organisms grew on culture plate? strep pneumoniae, candida parapsilosis, staph epidermidis, serratia marcescens.
 
Manufacturer Narrative
H.6 investigation summary.Customer reported a molecular false positive result.Neither photos nor returned good samples were received.Bd was unable to reproduce the customer¿s experience with the bactec product based on our internal procedures and the intended use of the product.Retention samples were visually inspected, tested for viable contamination by sub-culturing on tsa, chocolate, sabouraud and schaedler agars plates, voltage output and gram stain.All results were satisfactory.Batch history record review did not identify any evidence for which the customer submitted the complaint.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.Complaint is unconfirmed based on retention samples and batch history record review results.No corrective actions were required.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.
 
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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
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17764958
MDR Text Key323618268
Report Number3008352382-2023-00141
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904420239
UDI-Public00382904420239
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113558
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
Report Date 12/26/2023
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 Date11/09/2023
Device Catalogue Number442023
Device Lot Number3033390
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/25/2023
Initial Date FDA Received09/18/2023
Supplement Dates Manufacturer Received12/26/2023
Supplement Dates FDA Received01/09/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2023
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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