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 Leak/Splash (1354)

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

Event Date 09/19/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facs sample prep assistant ii leakage occurred at the bottom.The following information was provided by the initial reporter the instrument is leaking internally and that fluid is leaking out of the bottom of the instrument onto the countertop.

Manufacturer Narrative

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

Manufacturer Narrative

H.6 investigation summary (b)(4) pn: 337170 spaii sn: (b)(6) awareness: (b)(6) 2022 opened: (b)(6) 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: 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 (b)(6) 2021 to date (b)(6) 2022 (rolling 12 months) ¿ complaint trend: there are 4 complaints related to the reported complaint.Date range (date of incident to 12 months back) from (b)(6) 2021 to date (b)(6) 2022 (rolling 12 months) o (this complaint) ¿ investigation result / analysis: per fse¿s report: found the inline filter clogged.Flushed out the entire waste system from the wash tower to the waste bottle.Ran several primes with no overflowing or leaks.Ran a&p to verify the spa is operational and in specs.Flushing out the inline filter and waste line resolved the issue with the leaking o no further issues o sample preparation was not affected.O there was no delay in patient treatment due to any unexpected results.¿ service max review: review of related work order#(b)(4) install date: (b)(6) 2006 defective part number: there were no defective parts work order notes: o subject / reported: fluidic leak under instrument o problem description: fluidic leak o cause: clogged inline filter o work performed: unclogged filter ¿ flushed waste fluidic lines o solution: unclogged filter o parts replaced: there were no defective parts ¿ returned sample analysis: 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: o risk management file part #100245ra, revision 03 was reviewed.O hazard(s) identified? yes no hazard id: 3.1.29 hazard: environment biohazard cause: filter/components in the fluidic path get clogged harmful effects: exposure to biohazard residual severity: 5 residual probability: 1 residual risk index: 5 ¿ root cause: based on the investigation result and fse¿s report the root cause was a clogged in line filter and fluidic lines ¿ conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for a leaking under instrument.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.H3 other text : see h.10.

Event Description

It was reported that while using bd facs sample prep assistant ii leakage occurred at the bottom.The following information was provided by the initial reporter the instrument is leaking internally and that fluid is leaking out of the bottom of the instrument onto the countertop.

• 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: 15485558
• MDR Text Key: 300657326
• Report Number: 2916837-2022-00269
• 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: 01/20/2023

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: 09/19/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 01/20/2023
• Supplement Dates FDA Received: 01/25/2023
• 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