• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 10/09/2023
Event Type  malfunction  
Event Description
It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic), there were an unspecified number of molecular false positive results.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting molecular false positives for product 442023.".
 
Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information is as follows: g.5.Pma / 510(k)#: k222591.
 
Manufacturer Narrative
H.6.Investigation summary: catalog: 442023.Batch no.: unknown.Customer reported a molecular false positive result.Neither photos nor returned good samples were received.Bd was not able to perform an investigation to the retention samples since batch number is unknown.A complaint history review cannot be conducted relating to the incident lot number and the ¿as reported¿ defect code since batch number is unknown.The batch history record could not be reviewed as the lot number is unknown nonetheless batch history records are always reviewed prior to product release.Complaint is unconfirmed.
 
Event Description
It was reported that while using bd bactec¿ plus aerobic/f culture vials (plastic), there were an unspecified number of molecular false positive results.No patient impact reported.The following information was provided by the initial reporter: "customer is reporting molecular false positives for product 442023.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18015594
MDR Text Key326965278
Report Number2647876-2023-00374
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904420239
UDI-Public(01)00382904420239
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 11/23/2023
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 Catalogue Number442023
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/09/2023
Initial Date FDA Received10/26/2023
Supplement Dates Manufacturer Received11/23/2023
Supplement Dates FDA Received12/04/2023
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
-
-