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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SHEATH SOLUTION; GENERAL PURPOSE REAGENT
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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SHEATH SOLUTION; GENERAL PURPOSE REAGENT Back to Search Results
Catalog Number 336911
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2023
Event Type  malfunction  
Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.
 
Event Description
It was reported that the there was foreign matter/ contamination in the bd facs sheath solution.The following information was provided by the initial reporter: it seems that the same white suspended matter is floating in the solution in several pieces of the same lot (lot.2212409820) purchased at the same time, although they were opened at different times.Were there any erroneous results on patient samples? no.Whether carryover happened on patient samples? no.
 
Manufacturer Narrative
The following fields have been updated: g.1.Reporting office: becton dickinson and company bd biosciences g.2.Reporting office contact: fahmy razak - mdr g.4.Manufacturing site contact: fahmy razak - mdr h.6.Investigation summary: based on the investigation results, the reported issue 'white matter floating' was confirmed.Investigation results that were performed on the indicated failure mode were the following: picture provided by customer, crystal appearance precipitation was shown in the solution.Bhr part 336911 lot 2212409820 was reviewed.The materials met all the manufacturing specifications prior to release.There is no deviation noted from the production process.Potential cause - the white crystal could be either from product leakage or gotten old.Since the product is made in 2022, so it is likely the product had a leak during transportation or storage.The issue was resolved by providing the user a replacement lot.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the there was foreign matter/ contamination in the bd facs sheath solution.The following information was provided by the initial reporter: it seems that the same white suspended matter is floating in the solution in several pieces of the same lot (lot.2212409820) purchased at the same time, although they were opened at different times.Were there any erroneous results on patient samples? no.Whether carryover happened on patient samples? no.
 
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Brand Name
BD FACS SHEATH SOLUTION
Type of Device
GENERAL PURPOSE REAGENT
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
fahmy razak - mdr
2350 qume drive
san jose, CA 95131
4089542435
MDR Report Key17410145
MDR Text Key320684725
Report Number2916837-2023-00154
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 03/14/2024
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 Number336911
Device Lot Number2212409820
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/28/2023
Initial Date FDA Received07/27/2023
Supplement Dates Manufacturer Received03/14/2024
Supplement Dates FDA Received03/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2022
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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