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 09/09/2022

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.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 iii that the instrument is leaking liquid from the washing column and that no liquid is moving towards the waste.The following information was provided by the initial reporter that the customer reports that the instrument is leaking liquid from the washing column and that no liquid is moving towards the waste.Was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of fluid under pressure? no.What was the fluid that leaked? biohazard.Did bio- hazard before or after waste line? after waste line.Was the waste mixed with decontamination or bleach ? no.Was the customer or bd personnel physically in contact with the fluid ? no.

Manufacturer Narrative

H.6 investigation summary (b)(4), pn: 647205, spaiii, sn: (b)(6), date reported: 09/09/2022.Investigation summary: scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: leaking liquid from wash column.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 09sep2021 to date 09sep2022 (rolling 12 months).Complaint trend: there are 4 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 09sep2021 to date 09sep2022 (rolling 12 months).Complaint data attached.Investigation result / analysis: per fse¿s report: found the presence of rubber parts from perforation of the sample tube obstructing the drain.Clean checked that the liquid flowed optimally.Replaced sample needle supplied to the customer the instrument is fully functional 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: 08jun2020 defective part number: there were no defective parts work order notes: subject / reported: waste tower is leaking fluid problem description: wash tower is leaking fluid cause: clogged wash tower drain work performed: cleared blockage from the drain solution: cleared blockage from the drain returned sample evaluation: there were no defective parts manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(4) and pn647205 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 clogged waste drain conclusion: based on the investigation results and the call report the complaint was confirmed for wash tower leaking fluid.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.

Event Description

It was reported that while using bd facs¿ sample prep assistant iii that the instrument is leaking liquid from the washing column and that no liquid is moving towards the waste.The following information was provided by the initial reporter that the customer reports that the instrument is leaking liquid from the washing column and that no liquid is moving towards the waste.Was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of fluid under pressure? no.What was the fluid that leaked? biohazard.Did bio- hazard before or after waste line? after waste line.Was the waste mixed with decontamination or bleach ? no.Was the customer or bd personnel physically in contact with the fluid ? no.

• 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: 15451507
• MDR Text Key: 306272690
• Report Number: 2916837-2022-00261
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: (01)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: 12/05/2022

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: 09/09/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• 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