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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD; COUNTER, DIFFERENTIAL CELL

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BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD; COUNTER, DIFFERENTIAL CELL Back to Search Results
Model Number 338960
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: na.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 that while running bd facscanto ii cytometer 4/2 system ivd leaked biohazard waste.There was no user impact.The following information was provided by the initial reporter: was the leak fluid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of fluid under pressure? facsclean was leaking out of a connector at the filter.What was the fluid that leaked? biohazard.Did biohazard leak before or after waste line? before waste line.Was the waste mixed with decontamination or bleach? was the customer/bd personnel physically in contact with the fluid? no.Physical contact includes: clothing, skin, mucous membrane (e.G.Inhalation), and non-intact skin.".
 
Manufacturer Narrative
H6: investigation summary scope of issue: the scope of issue is only limited to bd facscanto ii cytometer 4/2/2 sys ivd part # 338960, serial # (b)(6).Problem statement: customer reported complaint of a leakage of biohazard not contained within the instrument.Manufacturing defect trend: there are (b)(4) qns (quality notifications) related to the reported issue.Date range from 31aug2020 to 31aug2021.Complaint trend: there are (b)(4) complaints related to the issue of leakage of biohazard not contained within the instrument.Date range from 31aug2020 to 31aug2021.Manufacturing device history record (dhr) review: dhr part # 338960 serial # (b)(6), file # (b)(4), was reviewed.The instrument met all the manufacturing specifications prior to release.Investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and servicemax, the root cause of the waste leakage not contained within the instrument was due to a worn waste connector.The customer had initially submitted a complaint regarding facsclean leaking out of the wet cart.An fse (field service engineer) was brought onsite for the repair, and they identified the source of the leakage to be a facsclean filter waste connector within the wet cart.The connector was replaced (pn 33304507) and a leak test was performed to verify the instrument was no longer leaking.No parts were requested for evaluation as the replaced part is not returnable and was discarded.After the repair the instrument was tested and confirmed to be performing as expected.Although the leakage of biohazard poses a risk of contamination if there is skin contact, the customer confirmed that they had not come in contact with the leakage.Additionally, there was no spray of fluid so the risk of exposure was minimal.While this instrument was being used for clinical diagnoses, the customer confirmed that the results gathered during the incident were not used and the patient was not affected in any way.The safety risk is limited, s2, and there was no impact to customer health or safety.Service max review: review of related work order #: (b)(4), case # (b)(4).Install date: (b)(6) 2012.Defective part number: n/a.Work order notes: o subject / reported: 338960 - bd facscanto ii cytometer 4/2 system ivd - facsclean has expired from the wet cart.O problem description: the complete facsclean ran out of the wet cart via nach.O work performed: troubleshooting carried out; wet card open; the connector on the facsclean filter is leaking; connector renewed (pn: 33304507); leak test carried out; startup carried out; optics checked; 7-color setup carried out: ok; device ok.O cause: connector leaking.O solution: failure had no effect on customer samples; the customer has not come into contact with the facsclean.Returned sample evaluation: a return sample was not requested because the replaced part is not returnable and was discarded.Risk analysis: risk management file part #338960-04ra, version a, bd facscanto ii flow cytometer (fluidics) fmea was reviewed.The severity rating in this file is ¿9¿ and the rpn is ¿18¿ based on the previous scale rating.This rating is equivalent to ¿s2¿ in sop6078-02 rev.12/vers.J, whereby the biohazard exposure is obvious or indicated by additional (warning) information and hence the impact to the customer is negligible to none.The current mitigations are adequate with rpn under acceptable range.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? yes no.O item: 6.Waste.O function: 6.1 contain waste.O potential failure mode: 6.1.1 waste not contained.O potential effect(s) of failure: 6.1.1.1 biohazards.O potential cause(s) / mechanism(s) of failure: 6.1.1.1.2 waste container overflows.O current controls: level sensor.O recommended actions: n/a.O responsible party: n/a.O target completion date: n/a.O actions taken: n/a.O sev: 9.O occ: 2.O det: 1.O rpn: 18.Mitigation(s) sufficient yes no.Root cause: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a worn waste connector.Conclusion: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a worn waste connector.The fse confirmed the issue was from a worn waste connector on the wetcart¿s facsclean filter.The fse replaced the part, tested the instrument, and confirmed that it was functioning as expected.No one was harmed or injured, and no medical treatment was performed due to the biohazardous leak.The safety risk is limited, s2, and there was no impact to customer health or safety.
 
Event Description
It was reported that while running bd facscanto ii cytometer 4/2 system ivd leaked biohazard waste.There was no user impact.The following information was provided by the initial reporter: was the leak fluid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of fluid under pressure? facsclean was leaking out of a connector at the filter.What was the fluid that leaked? biohazard.Did biohazard leak before or after waste line? before waste line.Was the waste mixed with decontamination or bleach? was the customer/bd personnel physically in contact with the fluid? no.Physical contact includes: clothing, skin, mucous membrane (e.G.Inhalation), and non-intact skin.".
 
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Brand Name
BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD
Type of Device
COUNTER, DIFFERENTIAL CELL
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12665711
MDR Text Key277416276
Report Number2916837-2021-00401
Device Sequence Number1
Product Code GKZ
UDI-Device Identifier00382903389605
UDI-Public00382903389605
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K062087
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 12/06/2021
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 Model Number338960
Device Catalogue Number338960
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/18/2021
Initial Date FDA Received10/20/2021
Supplement Dates Manufacturer Received12/06/2021
Supplement Dates FDA Received12/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2012
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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