MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SAMPLE PREP ASSISTANT II; STATION, PIPPETTING DILUTING CLINICAL

Catalog Number 337170

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/21/2021

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 the wash tower would not drain during use with bd facs sample prep assistant ii and biohazardous waste leaked outside of instrument.There was no user impact.The following information was provided by the initial reporter: it was reported by the customer that the wash tower does not drain 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.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

H6: investigation summary scope of issue: the scope of issue is limited to part: 337170 spaii and serial number: (b)(6).Problem statement: customer reported: wash tower 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 21sep2020 to date 21sep2021 (rolling 12 months).Complaint trend: there are 4 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 21sep2020 to date 21sep2021 (rolling 12 months).Investigation result / analysis: per fse report: replacement of main pump and filter assembly.After replacement verified performance by purging fluidics and ran a sample preparation.Instrument working correctly.Service max review: review of related work order# (b)(4).Install date: 07jul2005 defective part number: 334297 miniwash assembly, 640835 inline filter kit.Work order notes: subject / reported: wash station is overflowing; problem description: wash station pump clogged; cause: clogged wash pump; work performed: cleaned pump; solution: cleaned pump.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) dhr is archived.This spaii was installed in 2005.Manufacturing history of spaii units all passed/met requirements risk analysis: o risk management file part #100245ra, revision 02 was reviewed.O hazard(s) identified? yes; no.Hazard id: 3.1.29 _; hazard: environmental biohazard; severity: 5; ¿ probability: 1; 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 wash pump.Conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for the wash station does not drain.H3 other text : see h10.

Event Description

It was reported that the wash tower would not drain during use with bd facs sample prep assistant ii and biohazardous waste leaked outside of instrument.There was no user impact.The following information was provided by the initial reporter: it was reported by the customer that the wash tower does not drain.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.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 II
• Type of Device: STATION, PIPPETTING DILUTING CLINICAL
• 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: 12647724
• MDR Text Key: 276889833
• Report Number: 2916837-2021-00398
• Device Sequence Number: 1
• Product Code: JQW
• 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: 01/14/2022

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: 337170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/18/2022
• 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