Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 ANAEROBIC/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 ANAEROBIC/F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING Back to Search Results
Model Number 442022
Device Problem Labelling, Instructions for Use or Training Problem (1318)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2023
Event Type  malfunction  
Event Description
It was reported that bd bactec¿ plus anaerobic/f culture vials (plastic) organisms marked as clsi strains in the pi and coas do not match.The following information was provided by the initial reporter: organisms marked as clsi strains in the pi and coas do not match.
 
Manufacturer Narrative
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 bd bactec¿ plus anaerobic/f culture vials (plastic) organisms marked as clsi strains in the pi and coas do not match.The following information was provided by the initial reporter: organisms marked as clsi strains in the pi and coas do not match.
 
Manufacturer Narrative
H.6 investigation summary: catalog: 442022.Batch no.3060945.Customer reports that the clsi strains mentioned in certificate of analysis (coa) does not match those in the product insert (pi).Coa and pi were attached as evidence.Biological performance section in the coa and the pi were evaluated.Coa has two clsi strain references b.Fragilis (atcc 25285) and s.Pneumoniae (atcc 6305).The pi 8090999 (08) 2019-09 has one clsi strain reference b.Fragilis (atcc 25285).Batch history records review was performed.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 confirmed.An engineering change control was completed on (b)(6) 23 to change the clsi strain reference.Since the aforementioned date both coa¿s and pi¿s clsi strain references are the same.Quality control certificates list test organisms, including atcc® cultures specified in the clsi standard m22, quality control for commercially prepared microbiological culture media.Quality control requirements must be performed in accordance with applicable local, state and/or federal regulations or accreditation requirements and the laboratory¿s standard quality control procedures.It is recommended that the user refer to pertinent clsi guidance and clia regulations for appropriate quality control practices.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigational process.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD BACTEC¿ PLUS 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
phillip emmert
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key16678795
MDR Text Key312776583
Report Number3008352382-2023-00031
Device Sequence Number1
Product Code MDB
UDI-Device Identifier00382904420222
UDI-Public00382904420222
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K141810
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 05/10/2023
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 Date11/30/2023
Device Model Number442022
Device Catalogue Number442022
Device Lot Number3060945
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/15/2023
Initial Date FDA Received04/04/2023
Supplement Dates Manufacturer Received05/10/2023
Supplement Dates FDA Received05/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-