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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ CLEAN SOLUTION; GENERAL PURPOSE
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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ CLEAN SOLUTION; GENERAL PURPOSE Back to Search Results
Catalog Number 340345
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2022
Event Type  malfunction  
Event Description
It was reported that bd facs¿ clean solution had incorrect label information.The following information was provided by the initial reporter printed information of the lot number and the expiration date on the label affixed to the shelf carton has been replaced by each other.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
H.6.Investigation summary (b)(4).¿ scope of issue: solution part#: 340345 , bd facsclean 5l, lot #2201409824 ¿ problem statement: customer reported that they received a solution with lot and expiration date swapped around in the product label.¿ manufacturing defect trend: this product is manufactured by a third party.Manufacturing non-conformance data are not routinely available.¿ batch history record (bhr) review: batch production record for product 3928 was reviewed by the supplier.The materials met all the manufacturing specifications prior to release, and no deviations were reported.¿ complaint trend: there are 3 similar complaints, other than this complaint that were found.Date range from 15sep21 to 15sep22.¿ retain sample evaluation/testing: supplier has reviewed their retain sample, and identified impacted lots with labels.¿ returned sample evaluation: there is no sample returned, photo of label were provided and attached in the complaint.¿ investigation and root cause analysis: per supplier¿s note, as part of the investigation, they reviewed their process of printing labels and label management.They noted in 2021, there were changes made to the template of labels applied to bd products.In addition, their printing system has also changed.However, the interface between their erp system and the printing system was validated, hence there is no errors in the data transmission between the systems.Hence, the likely root cause of this complaint was the use of incorrect templates for printing labels.Impacted lots number were identified and communicated with bd quality.The supplier is in progress of implementing corrective action for this issue.(b)(4).¿ risk analysis ¿ this solution is a general purpose ivd class i product, which is an ancillary to the flow cytometer.It is not a component of the reagent or stained sample solution; it is not used in conjunction with cytometric data acquisition.Based on cpo-045, severity: s1, occurrence: o2 risk: low ¿ conclusion: based on the investigation result, the complaint is confirmed.¿ root cause: based on the investigation result, the complaint root cause is confirmed by the supplier.The supplier has implemented the corrective action for this issue.
 
Event Description
It was reported that bd facs¿ clean solution had incorrect label information.The following information was provided by the initial reporter printed information of the lot number and the expiration date on the label affixed to the shelf carton has been replaced by each other.
 
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Brand Name
BD FACS¿ CLEAN SOLUTION
Type of Device
GENERAL PURPOSE
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
2350 qume drive
san jose CA 95131
Manufacturer (Section G)
BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
2350 qume drive
san jose CA 95131
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15476781
MDR Text Key300657422
Report Number2916837-2022-00268
Device Sequence Number1
Product Code PPM
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
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 01/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/14/2023
Device Catalogue Number340345
Device Lot Number2201409824
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/26/2022
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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