MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ SAMPLE PREP ASSISTANT III; SEE H10

Model Number 647205

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/19/2021

Event Type  malfunction  

Event Description

It was reported that during use with bd facs¿ sample prep assistant iii biohazardous waste leaked outside of instrument.There was no patient/user impact.The following information was provided by the initial reporter: it was reported that the spa is leaking.Was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of liquid under pressure? no.What was the fluid that leaked? biohazard.Did biohazard leak before or after waste line? after waste line.Was the waste mixed with decontamination/bleach? no.Was the customer/bd personnel physically in contact with the fluid? no.

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: spa is leaking ¿ probe is bent.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6) 2021 (rolling 12 months) complaint trend: there are 11 complaints related to the reported complaint.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6) 2021 (rolling 12 months).Complaint data attached investigation result / analysis: per fse report: replaced probe with part onsite.Replaced fluidic tower waste coupling with part onsite.Tested and verified instrument.Service max review: review of related work order# (b)(4).Install date: (b)(6) 2018 defective part number: damaged coupling/probe work order notes: subject / reported: fluid leak and probe is bent problem description: fluidic leak cause: damaged coupling work performed: replaced damaged probe/coupling solution: replaced damaged probe/coupling 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:_alarp mitigation(s) sufficient yes/ no root cause: based on the investigation result and the fse¿s report the root cause was a damaged coupling conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for the spa leak and probe bent.

Event Description

It was reported that during use with bd facs¿ sample prep assistant iii biohazardous waste leaked outside of instrument.There was no patient/user impact.The following information was provided by the initial reporter: it was reported that the spa is leaking.1) was the leak liquid or air? liquid 2) was the leak contained within the instrument? not contained 3) was there spray of liquid under pressure? no 4) what was the fluid that leaked? biohazard 5) did biohazard leak before or after waste line? after waste line 6) was the waste mixed with decontamination/bleach? no 7) was the customer/bd personnel physically in contact with the fluid? no.

Manufacturer Narrative

H.6.Investigation: scope of issue: the scope of issue is limited to part: 647205 spaiii and serial number: (b)(6).Problem statement: customer reported: spa is leaking ¿ probe is bent.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 19nov2020 to date 19nov2021 (rolling 12 months) complaint trend: there are 11 complaints related to the reported complaint.Date range (date of incident to 12 months back) from (b)(6) 2020 to date (b)(6) 2021 (rolling 12 months) investigation result / analysis: per fse report: replaced probe with part onsite.Replaced fluidic tower waste coupling with part onsite.Tested and verified instrument.Service max review: review of related work order# (b)(4).Install date: (b)(6) 2018.Defective part number: damaged coupling/probe.Work order notes: subject / reported: fluid leak and probe is bent; problem description: fluidic leak; cause: damaged coupling; work performed: replaced damaged probe/coupling; solution: replaced damaged probe/coupling; returned sample evaluation: did not request return of defective parts.Manufacturing device history record (dhr) review: review of the dhr for serial number: r0506 and pn647205 was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #100245ra, revision 02 was reviewed.Hazard(s) identified? yes; 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:_alarp; mitigation(s) sufficient.Root cause: based on the investigation result and the fse¿s report the root cause was a damaged coupling conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for the spa leak and probe bent.

Event Description

It was reported that during use with bd facs¿ sample prep assistant iii biohazardous waste leaked outside of instrument.There was no patient/user impact.The following information was provided by the initial reporter: it was reported that the spa is leaking.1) was the leak liquid or air? liquid.2) was the leak contained within the instrument? not contained.3) was there spray of liquid under pressure? no.4) what was the fluid that leaked? biohazard.5) did biohazard leak before or after waste line? after waste line.6) was the waste mixed with decontamination/bleach? no.7) was the customer/bd personnel physically in contact with the fluid? no.

• Brand Name: BD FACS¿ SAMPLE PREP ASSISTANT III
• Type of Device: SEE H10
• 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: 13011581
• MDR Text Key: 282391758
• Report Number: 2916837-2021-00488
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131301
• 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: 03/04/2022

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: 11/19/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 02/17/2022; 03/04/2022
• Supplement Dates FDA Received: 02/24/2022; 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2017
• 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