MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD SAMPLE PREP ASSISTANT (SPA); STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

Catalog Number 337170

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/12/2021

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 while running bd sample prep assistant (spa) the wash station leaked biohazardous wastes outside instrument.There was no user impact.The following information was provided by the initial reporter: the wash station overflowing and it looks red.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? before waste line.Was the waste mixed with decontamination/bleach? was the customer/bd personnel physically in contact with the fluid? no.

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is limited to part: 337170 spaii and serial number: (b)(6) problem statement: customer reported: wash station is overflowing.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6) 2021 (rolling 12 months).Complaint trend: there are 2 complaints related to the reported complaint.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6) 2021 (rolling 12 months).Investigation result / analysis: per fse service call report: 1.Asked customer to clean inline filter.2.Customer cleaned the inline filter.Spa is operating with no issues.Customer confirmed case is closed.Service max review: review of related work install date: (b)(6) 2009 defective part number: there were no defective parts work order notes: subject / reported: wash station is overflowing.Problem description: fluidic clogg.Cause: clogged inline filter.Work performed: cleaned inline filter.Solution: cleaned inline 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 pn337170 was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part # (b)(4), 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 customer call report the root cause was clogged inline filter conclusion: based on the investigation results and the fse¿s customer call report the complaint was confirmed for the wash station overflow.

Event Description

It was reported that while running bd sample prep assistant (spa) the wash station leaked biohazardous wastes outside instrument.There was no user impact.The following information was provided by the initial reporter: the wash station overflowing and it looks red.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? before waste line.6) was the waste mixed with decontamination/bleach? 7) was the customer/bd personnel physically in contact with the fluid? no.

• Brand Name: BD SAMPLE PREP ASSISTANT (SPA)
• Type of Device: STATION, PIPETTING AND DILUTING, FOR CLINICAL USE
• 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: 12770803
• MDR Text Key: 281854817
• Report Number: 2916837-2021-00431
• 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: 02/15/2022

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: 10/12/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 02/23/2022
• 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