MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSARIA¿ III; FLOW CYTOMETER

Catalog Number 648282B3

Device Problems Leak/Splash (1354); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).Investigation summary: scope of issue: when connecting instrument supply line to ethanol filter, some ethanol squirted out.The user did not depressurize ethanol tank before connecting and some liquid squirted on the user's glasses.Defect trend: qns (zm, ze) related to this issue in sap from 08/may/2018 to 09/may/2019 = 0.Complaint trend: based on complaint data from 08/may/2018 to 09/may/2019, this is the only complaint related to user connecting the filter to the tank while it was pressurized.The fluid can be either sheath or ethanol.Investigation result / analysis: ¿ when connecting instrument supply line to ethanol filter, some ethanol squirted out.¿ the user did not depressurize the ethanol tank per bd facsaria iii user¿s guide (23-15132-01, rev 01, page 216-217) and user's bulletin (23-21212-00, rev 01, page 2) resulting some liquid squirted on the user's glasses due to the tank pressure.¿ the plastic of the user's glasses was damaged but no physical harm occurred to the user.Per instructions in the bd sheath/ethanol filter user's bulletin (23-21212-00, rev 01, page 2) and in the bd facsaria iii user¿s guide (23-15132-01, rev 01, page 216-217), users are instructed to release the pressure from the tank and also perform the verification of pressure is release before by disconnection or connecting of filter."procedure to change the sheath/ethanol filter: turn off the stream.Disconnect the air line from the sheath tank.Pull up on the ring of the pressure relief valve to release the pressure from the tank.Verify that all of the pressure is released by pulling up a second time.Disconnect the filter by pressing the metal tabs on each end.Write the current date on the filter so that you will know when to replace it.Use the arrows on the filter that indicate the direction of the flow through the filter; replace the filter with a new one in the same orientation.Reconnect the air line and check for leaks when the pressure is turned on." in addition, per bd facsaria fusion safety and limitations guide (23-14817-00, rev 01, page 23), users are instructed to ¿wear suitable protective clothing, eyewear, and gloves.¿ as personal protective equipment (ppe) should be worn when operating the instrument.Assignable cause: the user did not depressurize the ethanol tank per bd facsaria iii user¿s guide (23-15132-01, rev 01, page 216-217) and bd sheath/ethanol filter user's bulletin (23-21212-00, rev 01, page 2) before reconnecting the filter, resulting in some liquid squirted on the user's personal glasses (plastic) due to residual tank pressure.Return goods authorization (rga)/ return material authorization (rma) returned sample evaluation: no request was made for the ethanol filter to be returned.Sample management task 952933 was created on 13may2019, closed on 14may2019 stating, ¿the filter was not defective.The user was inexperienced and connected the filter to the tank while it was still under pressure.The connector was not damaged and the customer does not wish to replace the filter¿.Result of device history record (dhr) review: reviewed 648282-648282-p64828200041-100015880-12.No issues related to this failure mode were identified.Risk analysis (sop6078-03): reviewed 648282ra, rev 07 - risk analysis facs aria iii.The risk analysis does not identify the applicable hazards related to this nonconformance.Frequency - based on complaint data from 08/may/2018 to 09/may/2019, this is the only one (1) complaint related to liquid squirted due to tank not depressurize by user.Severity - the severity of this hazard (liquid squirted from filter) is determined as s3 moderate based on health hazard evaluation (hhe) #bdb-19-1393-hhe.Investigation conclusion: complaint confirmed.The user did not depressurize ethanol tank before disconnecting the filter per bd facsaria iii user¿s guide (23-15132-01, rev 01, page 216-217) and bd sheath/ethanol filter user's bulletin (23-21212-00, rev 01, page 2) resulting liquid squirted on the users glasses due to residual tank pressure.This is the only complaint from 08/may/2018 to 09/may/2019 related to user connecting the filter to the tank while it was pressurized.Root cause description: assignable cause: the user did not depressurize the ethanol tank per bd facsaria iii user¿s guide (23-15132-01, rev 01, page 216-217) and bd sheath/ethanol filter user's bulletin (23-21212-00, rev 01, page 2) and some liquid squirted due to residual tank pressure.

Event Description

It was reported that while using a bd facsaria¿ iii flow cytometer the lab technician was connecting the instrument ethanol supply line.The user did not depressurize the instrument prior to connecting the line and pressurised ethanol sprayed into the users face.The user reported their plastic glasses were damaged, but that they did not get fluid in their eyes.The following information was provided by the initial reporter: "when connecting instrument supply line to ethanol filter, some ethanol squirts out.User didn't depressurize etoh tank before connecting and some liquid squirted on the user's glasses.The plastic of the glasses was damaged but no physical harm occured to the user.This however poses a potential security risk, the lab manager would like to have an intermediate connecting piece installed on the etoh filter to avoid such an event in the future.The safer connecting piece is currently already installed on the sheath filter part (metal male quick con - tubing - female metal quick con).".

• Brand Name: BD FACSARIA¿ III
• Type of Device: FLOW CYTOMETER
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8677138
• MDR Text Key: 208783406
• Report Number: 2916837-2019-00109
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: RUO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 648282B3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other