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 06/02/2022

Event Type  malfunction  

Event Description

It was reported that while using bd facs sample prep assistant ii leakage of biohazard not contained within instrument.There was no report of user impact.The following information was provided by the initial reporter: it was reported by the customer wash tower overflowing.Was the leak liquid or air? (if liquid/both, go to question #2.If air, no further questions required.):liquid.Was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.):not contained.Was there spray of liquid? (if yes, describe the liquid that sprayed then go to question #7.If no, type "no" in the text box then go to question #4):no what was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/unknown, go to question #5):biohazard.Did biohazard leak before or after waste line? (if before waste line or unknown, go to question #7.If after waste line, go to question #6):before waste line.Was the waste mixed with decontamination/bleach? (if no, go to question #7.If yes, no further questions required.):no.Was the customer/bd personnel physically in contact with the fluid? (if yes, go to question #8.If no, no further questions required.) physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: yes.Where did the physical contact of fluid occur? (please describe then go to question #9):sample probe wash well overflowed onto the spa deck.What personal protective equipment (ppe) was being used during the occurence? (please describe then go to question #10):latex gloves.Was there any impact to patient samples due to leak? (if yes, go to patient samples checklist.If no, go to question #11):no.Was customer/bd personnel harmed/injured? (if yes, provide details - how and to what extent? then go to question #12.If no, no further questions required.):no.What is the current medical status? (please describe.No further questions required.):no harm incurred.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following information from the device evaluation has been corrected: ¿ root cause: based on the investigation result and the fse¿s report the root cause was a clogged waste pump.

Event Description

It was reported that while using bd facs sample prep assistant ii leakage of biohazard not contained within instrument.There was no report of user impact.The following information was provided by the initial reporter: it was reported by the customer wash tower overflowing.1.Was the leak liquid or air? (if liquid/both, go to question #2.If air, no further questions required.):liquid.2.Was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.):not contained.3.Was there spray of liquid? (if yes, describe the liquid that sprayed then go to question #7.If no, type "no" in the text box then go to question #4):no.4.What was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/unknown, go to question #5):biohazard.5.Did biohazard leak before or after waste line? (if before waste line or unknown, go to question #7.If after waste line, go to question #6):before waste line.6.Was the waste mixed with decontamination/bleach? (if no, go to question #7.If yes, no further questions required.):no.7.Was the customer/bd personnel physically in contact with the fluid? (if yes, go to question #8.If no, no further questions required.) physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: yes.8.Where did the physical contact of fluid occur? (please describe then go to question #9):sample probe wash well overflowed onto the spa deck 9.What personal protective equipment (ppe) was being used during the occurance? (please describe then go to question #10):latex gloves.10.Was there any impact to patient samples due to leak? (if yes, go to patient samples checklist.If no, go to question #11):no.11.Was customer/bd personnel harmed/injured? (if yes, provide details - how and to what extent? then go to question #12.If no, no further questions required.):no.12.What is the current medical status? (please describe.No further questions required.):no harm incurred.

Event Description

It was reported that while using bd facs sample prep assistant ii leakage of biohazard not contained within instrument.There was no report of user impact.The following information was provided by the initial reporter: it was reported by the customer wash tower overflowing.1.Was the leak liquid or air? (if liquid/both, go to question #2.If air, no further questions required.): liquid.2.Was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.): not contained.3.Was there spray of liquid? (if yes, describe the liquid that sprayed then go to question #7.If no, type "no" in the text box then go to question #4): no.4.What was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/unknown, go to question #5): biohazard.5.Did biohazard leak before or after waste line? (if before waste line or unknown, go to question #7.If after waste line, go to question #6): before waste line.6.Was the waste mixed with decontamination/bleach? (if no, go to question #7.If yes, no further questions required.): no.7.Was the customer/bd personnel physically in contact with the fluid? (if yes, go to question #8.If no, no further questions required.) physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: yes.8.Where did the physical contact of fluid occur? (please describe then go to question #9):sample probe wash well overflowed onto the spa deck.9.What personal protective equipment (ppe) was being used during the occurance? (please describe then go to question #10):latex gloves.10.Was there any impact to patient samples due to leak? (if yes, go to patient samples checklist.If no, go to question #11): no.11.Was customer/bd personnel harmed/injured? (if yes, provide details - how and to what extent? then go to question #12.If no, no further questions required.): no.12.What is the current medical status? (please describe.No further questions required.): no harm incurred.

Manufacturer Narrative

The following additional information was included: d.9.Device available for eval? yes.D.9 returned to manufacturer on: 09-jun-2022.H.2 device return to manuf.?: yes.H.2 device eval by manufacturer?: yes.Investigation summary: ¿ scope of issue: the scope of issue is limited to part: 337170 spaii and serial number: (b)(6).¿ problem statement: customer reported: instrument is not draining.Wash station overflowing.¿ manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 02jun2021 to date 02jun2022 (rolling 12 months).¿ complaint trend: there are 2 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 02jun2021 to date 02jun2022 (rolling 12 months).O (b)(4) (this complaint).¿ investigation result / analysis: per fse report: consult with customer.The sample probe wash well overflowed onto the spa deck.Before the waste line.O remove and inspect in-line filter.Clear.Backflush fluidic line to wash station.No clogs.O flush fluidic line to waste tank.No clogs.O disassemble waste pump.Clean ports and seals of any accumulated debris.Reassemble and test.No problem observed.Wash tower drains normally.O test wash tower flow by performing multiple primes.No problem observed.O ppe is worn by the operators.O sample preparation was not affected.O no one was harmed or injured.¿ service max review: review of related work order# 02477806.Install date: 01jul2008.Defective part number: there were no defective parts.Work order notes: o subject / reported: wash station is not draining.O problem description: wash station is not draining, its overflowing.O cause: cannot be determined.O work performed: preventive maintenance: cleaned/inspected fluidic path.O solution: cleaned/inspected fluidic path.¿ returned sample evaluation: there were no defective parts.¿ manufacturing device history record (dhr) review: review of the dhr for serial number: t0364 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 or no? o hazard id: (b)(4).O hazard: environmental biohazard.O severity: 5.O probability: 1.O risk index: 5.O implementation: bd facs sample prep user¿s guide.O risk control: afap.O mitigation(s) sufficient: yes or no? ¿ root cause: based on the investigation result and the fse¿s report the root cause cannot be determined.¿ conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for wash station overflow.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: 14674864
• MDR Text Key: 294416695
• Report Number: 2916837-2022-00151
• 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,Followup
• Report Date: 07/26/2022

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: Health Professional
• Device Catalogue Number: 337170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 07/13/2022; 07/26/2022
• Supplement Dates FDA Received: 07/15/2022; 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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