MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT III; SEE H.10

Model Number 647205

Device Problem Leak/Splash (1354)

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

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen processing.Workstations for flow cytometric analysis.Medical device expiration date: unknown.Initial reporter phone number: (b)(6).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 by the customer that bd facs¿ sample prep assistant iii had waste leakage without bleach not contained outside the instrument.There was one occurrence in this event with no patient impact.The following information was provided by the customer: "the customer reports that the scrubber has overflowed and the waste liquid has spilled under the instrument." 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): after 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.: no.

Event Description

It was reported by the customer that bd facs¿ sample prep assistant iii had waste leakage without bleach not contained outside the instrument.There was one occurrence in this event with no patient impact.The following information was provided by the customer: "the customer reports that the scrubber has overflowed and the waste liquid has spilled under the instrument." 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): after 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.: no.

Manufacturer Narrative

H.6 investigation summary: pr5980897 pn: 647205 spaiii, sn: (b)(6), date reported: 09/02/2022.Investigation summary: scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: (scrubber) wash tower overflowed ¿ liquid spilled.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 3 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).(this complaint).Investigation result / analysis: per fse¿s report: during the field intervention, the problem was not encountered: positive check of the waste suction pump operation, control of the entire discharge line (pipes / fitting) without encountering any type of obstruction.Disassembly of the washing column: free drain fitting, residues of the caps of the primary sample tubes are found and therefore a complete internal cleaning is carried out.Check exhaust filter (in use and of the two spare): the filter had already been cleaned by the customer, it is positively verified that the fittings have no obstructions.Repeated priming / washing cycles and a successful 20 sample run are performed.Equipment regularly functioning according to bd specifications.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# 02600163.Install date: (b)(6) 2019.Defective part number: there were no defective parts work order notes: subject / reported: waste tower overflowed, problem description: the reported problem did not occur, cause: cannot be determined, work performed: cleared particles/residue from drain/fittings, solution: cleared particles/residue from drain/fittings.Returned sample evaluation: there were no 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 undetermined.Conclusion: based on the investigation results and the fse report the complaint was unconfirmed for wash tower overflowed.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 III
• Type of Device: SEE H.10
• 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: 15440445
• MDR Text Key: 302725304
• Report Number: 2916837-2022-00252
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

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 Model Number: 647205
• Device Catalogue Number: 647205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2022
• Initial Date FDA Received: 09/16/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2017
• 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