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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD DIFCO¿ FLUID A, 300 ML; CYTOTOXICITY ASSAY
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BECTON, DICKINSON & CO. (SPARKS) BD DIFCO¿ FLUID A, 300 ML; CYTOTOXICITY ASSAY Back to Search Results
Catalog Number 290652
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported bd difco¿ fluid a, 300 ml had a device marking issue, with no label present on the bottle.The following information was provided by the initial reporter: "fluid a 290652 missing label".
 
Event Description
It was reported bd difco¿ fluid a, 300 ml had a device marking issue, with no label present on the bottle.The following information was provided by the initial reporter: "fluid a 290652 missing label.".
 
Manufacturer Narrative
H.6 investigation summary: material 290652 is manufactured by rehydrating the media components with usp purified water and thoroughly mixing until a homogeneous solution is obtained.The media is dispensed into bottles; caps are applied manually then torqued by machine per a standard operating procedure (sop).The bottles are then labeled and terminally autoclaved in an air over pressure (aop) autoclave, per manufacturing instructions, using a validated cycle.Post autoclaving, bottles are packaged into final shipping configurations.The batch history record review for batch 1323774 was satisfactory and no quality notifications were generated during manufacturing and inspection.Filtering, filling and labeling processes were within specifications.Qc inspection and testing were satisfactory at time of release.The complaint history was reviewed, and no other complaints have been taken on this batch.Retention samples from batch 1323774 (10 bottles) were available for inspection.No defects were observed in 10/10 retention bottles.All 10/10 retention bottles had one properly affixed legible label.Two photos were received to assist with the investigation: the first photo shows one bottle without a label.No product information is presented in the photo.The second photo also shows one bottle without a label.No product information is presented in the photo.Without product verification a photo alone cannot confirm a complaint.A photo must provide the product, the defect, and the product label or carton that provides the product batch/lot number.This complaint cannot be confirmed from the photos provided.Bd will continue to trend complaints for labeling.H3 other text : see h.10.
 
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Brand Name
BD DIFCO¿ FLUID A, 300 ML
Type of Device
CYTOTOXICITY ASSAY
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer (Section G)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14282355
MDR Text Key299588799
Report Number1119779-2022-00644
Device Sequence Number1
Product Code MCB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
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 06/30/2022
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 Date11/16/2022
Device Catalogue Number290652
Device Lot Number1323774
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2022
Initial Date FDA Received05/04/2022
Supplement Dates Manufacturer Received06/30/2022
Supplement Dates FDA Received07/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2021
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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