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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD FOCAL POINT"120V / 15 FOV (REFURBISHED); PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
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BECTON, DICKINSON & CO. (SPARKS) BD FOCAL POINT"120V / 15 FOV (REFURBISHED); PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED Back to Search Results
Catalog Number 490398
Device Problem False Negative Result (1225)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/27/2023
Event Type  malfunction  
Event Description
It was reported that during use with the bd focal point 120v / 15 fov (refurbished), false negative results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: there was a variance where low grade cells were not found by the focal point but found during qc.No erroneous reports were sent out.
 
Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.6 investigation summary: this complaint alleges false negative result on the focalpoint instrument (p/n 490398, s/n (b)(6)).The customer called in to report that they found low grade cells on the slide outside of the field of view (fov's).The initial report was corrected before results were sent to the patient.Per the focalpoint gs false negative test work instruction with 1 false negative reported, the machine is operating within claims.This work instruction provides methodology for determining whether the system is operating within the product insert claims based on clinical trial data.Samples were not received by quality for investigation and thus, returned material investigation could not occur.Review of device history record is not required because this complaint does not allege an early life failure or failure at installation and has changed configuration since release from manufacturing due to service repairs/pms.Service history review was performed for the instrument and no additional work orders were observed for the complaint failure mode reported.The root cause is unknown at this time.This complaint is unconfirmed as the sample was not returned for investigation.Bd will continue to closely monitor trends associated with this complaint.Complaint history for results was reviewed for the month of june.The upper control limit was not breached, and trends were not identified associated with this defect.
 
Event Description
It was reported that during use with the bd focal point 120v / 15 fov (refurbished), false negative results were obtained.There was no report of patient impact.The following information was provided by the initial reporter: there was a variance where low grade cells were not found by the focal point but found during qc.No erroneous reports were sent out.
 
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Brand Name
BD FOCAL POINT"120V / 15 FOV (REFURBISHED)
Type of Device
PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
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
8448235433
MDR Report Key17243276
MDR Text Key318377660
Report Number1119779-2023-00728
Device Sequence Number1
Product Code MKQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970009
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 08/12/2023
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 Number490398
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/27/2023
Initial Date FDA Received06/30/2023
Supplement Dates Manufacturer Received08/11/2023
Supplement Dates FDA Received08/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/27/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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