MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT; SEE SECTION H10

Catalog Number 650685

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2021

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, dilution and specimen processing workstations for flow cytometric analysis.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 biohazard liquid leaked outside of the bd facs¿ sample prep assistant when it wouldn't drain properly.There was no adverse user or patient impact.The following information was provided by the initial reporter: "wash tower does not drain and fluid leaked out onto the table top" were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of liquid? no.What was the fluid that leaked? biohazard.Did biohazard leak before or after the waste line? after waste line.Was the waste mixed with decontaminate/bleach? no.Was the customer/bd personnel physically in contact with the fluid? no.

Event Description

It was reported that biohazard liquid leaked outside of the bd facs¿ sample prep assistant when it wouldn't drain properly.There was no adverse user or patient impact.The following information was provided by the initial reporter: "wash tower does not drain and fluid leaked out onto the table top".Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of liquid? no.What was the fluid that leaked? biohazard.Did biohazard leak before or after the waste line? after waste line.Was the waste mixed with decontaminate/bleach? no.Was the customer/bd personnel physically in contact with the fluid? no.

Manufacturer Narrative

H6: investigation summary scope of issue: the scope of issue is limited to part: 650685 spaiii and serial number: (b)(6).Problem statement: customer reported: wash station does not drain.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 28aug2020 to date 28aug2021 (rolling 12 months).Complaint trend: there are 4 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 28aug2020 to date 28aug2021 (rolling 12 months).Investigation result / analysis: per fse report: found debris inside waste pump.Cleaned out pump and verified.The instrument is up and running and passed verification.No additional issues noted.Service max review: review of related work order# (b)(4).Install date: 31mar2005.Defective part number: there were no defective parts.Work order notes: o subject / reported: wash station does not drain.O problem description: wash station does not drain.O cause: clogged waste pump.O work performed: cleaned out pump.O solution: cleaned out pump.Returned sample evaluation: there were no defective parts.Manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: o risk management file part #100245ra, revision 02 was reviewed.O hazard(s) identified? yes? no? o hazard id: 3.1.29.O hazard: environmental biohazard.O severity: 5.O probability: 1.O risk index: 5.O implementation: bd facs sample prep user¿s guide.O risk control:_alarp.O mitigation(s) sufficient? yes? no? root cause: based on the investigation result and the fse¿s comments the root cause was clogged waste pump.Conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for the wash station does not drain.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT
• Type of Device: SEE SECTION H10
• 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 Key: 12836927
• MDR Text Key: 282391685
• Report Number: 2916837-2021-00447
• Device Sequence Number: 1
• Product Code: PER
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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: 12/02/2021

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 Catalogue Number: 650685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 12/02/2021
• Supplement Dates FDA Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1