MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT; SEE H.10

Catalog Number 650686

Device Problem Leak/Splash (1354)

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

Event Date 05/17/2022

Event Type  malfunction  

Event Description

It was reported that during with a bd facs¿ sample prep assistant waste leaked underneath the instrument.There was no user impact.The following information was provided by the initial reporter: it was reported by the customer fluid leak under instrument.Was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of liquid under pressure? no.What was the fluid that leaked? unknown.Did biohazard leak before or after waste line? after waste line.Was the waste mixed with decontamination/bleach? no.Was the customer/bd personnel physically in contact with the fluid? no.

Manufacturer Narrative

Common device name: automated pipetting, diluting 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.

Manufacturer Narrative

Investigation summary: scope of issue: the scope of issue is limited to part: 650686 spaiii and serial number: (b)(6).Problem statement: customer reported: waste leakage.Fluid leak under instrument manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 17may2021 to date 17may2022 (rolling 12 months).Complaint trend: there are 3 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 17may2021 to date 17may2022 (rolling 12 months).Investigation result / analysis: per fse report: found: wash tower overflowed.Observed that the leak was contained inside the spa next to the wash tower fluid leaked: sheath fluid lubricated and reseated inline filter quick disconnect ppe is worn by the operators sample preparation was not affected.No one was harmed or injured service max review: review of related work order install date: 11jan2007 defective part number: there were no defective parts work order notes: subject / reported: wash tower overflowed problem description: wash station overflowing cause: in line filter not seated work performed: reseated in-line filter solution: reseated in-line filter returned sample evaluation: there were no defective parts manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and pn650686 was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #100245ra, revision 03 was reviewed.Hazard(s) identified? yes no.Hazard id: 3.1.29 _ hazard: environmental biohazard severity: 5 probability: 1 risk index: 5 implementation: bd facs sample prep user¿s guide__ risk control: afap mitigation(s) sufficient yes no root cause: based on the investigation result and the fse¿s report the root cause was the in-line filter was not seated properly.Conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for wash tower overflow.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.There was no impact to the patient health or safety.

Event Description

It was reported that during with a bd facs¿ sample prep assistant waste leaked underneath the instrument.There was no user impact.The following information was provided by the initial reporter: it was reported by the customer fluid leak under instrument.1) was the leak liquid or air? liquid.2) was the leak contained within the instrument? not contained 3) was there spray of liquid under pressure? no 4) what was the fluid that leaked? unknown 5) did biohazard leak before or after waste line? after waste line.6) was the waste mixed with decontamination/bleach? no.7) was the customer/bd personnel physically in contact with the fluid? no.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT
• Type of Device: SEE H.10
• 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 Key: 14744643
• MDR Text Key: 300216912
• Report Number: 2916837-2022-00154
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

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: 650686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 05/24/2022
• Initial Date FDA Received: 06/20/2022
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 07/27/2022
• 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