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

Model Number 647205

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/10/2021

Event Type  malfunction  

Manufacturer Narrative

Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.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 that bd facs¿ sample prep assistant iii leaked biohazard that was not contained in the instrument.The following information was provided by the initial reporter: "the waste station is overflowing.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? physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: 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: wash station is overflowing.¿ manufacturing defect trend: there are (b)(4) qns related to the reported issue.Date range (date of incident to 12 months back) from 10dec2020 to date 10dec2021 (rolling 12 months).¿ complaint trend: there are (b)(4) complaints related to the reported complaint.Date range (date of incident to 12 months back) from 10dec2020 to date 10dec2021 (rolling 12 months).O complaint data attached.¿ investigation result / analysis: per fse report: replicated wash station overflow.Flushed each of the connectors, fittings, tubing from wash station to waste tank.Changed one fitting with o-ring damaged.Changed pn 334297 pump mini wash assembly.And cleaned thoroughly waste station.Tested different cleaning procedures and priming.No more issues detected.Pump works well.System is performing to specifications.¿ service max review: review of related work order ¿ (b)(4).Install date: (b)(6) 2012.Defective part number: 334297 ¿ miniwash assembly.Work order notes: o subject / reported: wash station is overflowing.O problem description: fluid leak.O cause: waste pump not working.O work performed: replaced waste pump.O solution: replaced waste pump.¿ returned sample evaluation: did not request return of 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:.O risk management file part #100245ra, revision 03 was reviewed.O hazard(s) identified? yes no.Hazard id: 3.1.29 _.Hazard: environmental biohazard.Severity: 5.Probability: 1.Risk index: 5.O implementation: bd facs sample prep user¿s guide__.O risk control:_alarp_____.O mitigation(s) sufficient yes no.¿ root cause: based on the investigation result and the fse¿s report the root cause was waste pump not working.¿ conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for the wash station flooding.

Event Description

It was reported that bd facs¿ sample prep assistant iii leaked biohazard that was not contained in the instrument.The following information was provided by the initial reporter: "the waste station is overflowing.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? physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: no".

Event Description

It was reported that bd facs¿ sample prep assistant iii leaked biohazard that was not contained in the instrument.The following information was provided by the initial reporter: "the waste station is overflowing.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? physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: 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: wash station is overflowing manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 10dec2020 to date 10dec2021 (rolling 12 months) complaint trend: there are 11 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 10dec2020 to date 10dec2021 (rolling 12 months) investigation result / analysis: per fse report: replicated wash station overflow.Flushed each of the connectors, fittings, tubing from wash station to waste tank.Changed one fitting with o-ring damaged.Changed pn 334297 pump mini wash assembly.And cleaned thoroughly waste station.Tested different cleaning procedures and priming.No more issues detected.Pump works well.System is performing to specifications service max review: review of related work order ¿ (b)(4).Install date: 03apr2012 defective part number: 334297 ¿ miniwash assembly work order notes: subject / reported: wash station is overflowing, problem description: fluid leak, cause: waste pump not working, work performed: replaced waste pump , solution: replaced waste pump.Returned sample evaluation: did not request return of defective parts manufacturing device history record (dhr) review: review of the dhr for serial number: x0201 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.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 waste pump not working conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for the wash station flooding h3 other text : see h.10.

• 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: 13064636
• MDR Text Key: 283609722
• Report Number: 2916837-2021-00498
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• 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: 12/10/2021
• Initial Date FDA Received: 12/22/2021
• 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: 05/06/2013
• 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