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

Catalog Number 650686

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/20/2021

Event Type  malfunction  

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.

Event Description

It was reported that while running bd facs¿ sample prep assistant the waste tower leaked outside of instrument.The following information was provided by the initial reporter: waste tower overflowing.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? biohazard.

Event Description

It was reported that while running bd facs¿ sample prep assistant the waste tower leaked outside of instrument.The following information was provided by the initial reporter: waste tower overflowing.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? biohazard.

Manufacturer Narrative

H6: investigation summary scope of issue: the scope of issue is limited to part: 650686 spaiii and serial number: (b)(6).Problem statement: customer reported: wash tower is overflowing.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 20sep2020 to date 20sep2021 (rolling 12 months).Complaint trend: there are 6 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 20sep2020 to date 20sep2021 (rolling 12 months).Investigation result / analysis: per fse report: replaced the waste pump and 4-way valve.Instrument operating within specifications.Service max review: review of related work order# (b)(4); install date: 29oct2007; defective part number: 334297 miniwash asm, 642440 valve 4-way.Work order notes: subject / reported: wash station overflowing; problem description: wash station overflowing; cause: clogged waste pump filter and 4-way valve; work performed: replaced waste pump and 4-way valve; solution: replaced waste pump and 4-way valve.Returned sample evaluation: did not request return of 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: risk management file part #100245ra, revision 02 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:_alarp_____; mitigation(s) sufficient yes; no.Root cause: based on the investigation result and the fse¿s comments the root cause was defective pump and 4-way valve conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for the wash station overflowing.H3 other text : see h10.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT
• Type of Device: SEE 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: 12883686
• MDR Text Key: 284385724
• Report Number: 2916837-2021-00469
• 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: 12/21/2021

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: 650686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 11/29/2021
• Supplement Dates Manufacturer Received: 12/21/2021
• Supplement Dates FDA Received: 01/05/2022
• 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