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 08/29/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facs sample prep assistant ii washstation overflow occurred.The following information was provided by the initial reporter: "spoke with (b)(6) ans she explained that on friday their fse was onsite to repair their spa that was having wash station overflow, the spa worked fine but then today they started experiencing wash station overflows again.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd facs sample prep assistant ii wash station overflow occurred.The following information was provided by the initial reporter: "spoke with (b)(6), she explained that on friday their fse was onsite to repair their spa that was having wash station overflow, the spa worked fine but then today they started experiencing wash station overflows again.".

Manufacturer Narrative

H.6 investigation summary: (b)(4), pn: 337170, spaii, sn: (b)(6), date reported: 08/29/2022.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 is overflowing.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from on (b)(6) 2021 to date on (b)(6) 2022 (rolling 12 months).Complaint trend: there are 8 complaints related to the reported complaint.Date range (date of incident to 12 months back) from on (b)(6) 2021 to date on (b)(6) 2022 (rolling 12 months).Investigation result / analysis: per fse¿s report: replaced the clogged fittings and flushed the rest of the waste line and in-line filter.Full waste flow volume has been restored.The wash station is no longer overflowing.The instrument is operating as intended and is testing without errors.Returned the instrument to the lab for normal use.No further issues sample preparation was not affected.There was no delay in patient treatment due to any unexpected results.Service max review: review of related work order#: (b)(4).Install date: on (b)(6) 2006.Defective part number: 640521 ¿ coupling insert valve.Work order notes: subject / reported: wash tower is overflowing problem description: fluid leak cause: clogged fluidic line fittings work performed: replaced clogged fittings solution: replaced clogged fittings.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 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 a clogged fittings.Conclusion: based on the investigation results the complaint was confirmed for wash tower overflowing.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.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15506924
• MDR Text Key: 306318653
• Report Number: 2916837-2022-00249
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

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: 08/29/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 10/31/2022
• Supplement Dates FDA Received: 11/02/2022
• 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