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 Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2020

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported while using bd facs¿ sample prep assistant iii biohazard leaked outside of instrument.There was no reported impact to customer or patient.The following information was provided by the initial reporter: it was reported that pieces of yellow rubber top are breaking off, and getting into the instrument causing it to clog and spill out onto the floor.Are you using this for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Contamination checklist from case: were samples contaminated? no.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.What was the fluid that leaked? waste.What is the source of leak waste line or non-waste line? waste line.Was the customer exposed to blood or bodily fluids? yes.Was there any physical harm to the customer as a result of the leak? no.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? unknown.Was the waste mixed with decontamination/bleach? no.Was the customer/bd personnel physically in contact with the fluid? yes.Where did the physical contact of fluid occur? customer in contact with the fluids, but they were wearing their ppe, which consisted of lab coats, gloves, and face-shield to clean up spill.No fluids were on actually contacted on customer's skin or clothes.What personal protective equipment was being used during the occurrence? gloves, lab coats, face-shields.Was there any impact to patient samples due to leak? no.Was customer/bd personnel harmed/injured? no.

Event Description

It was reported while using bd facs¿ sample prep assistant iii biohazard leaked outside of instrument.There was no reported impact to customer or patient.The following information was provided by the initial reporter: it was reported that pieces of yellow rubber top are breaking off and getting into the instrument causing it to clog and spill out onto the floor.Are you using this for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Contamination checklist from case 1) were samples contaminated? no.Was the leak contained within the instrument? no.Was the leak in a customer accessible location? yes.What was the fluid that leaked? waste.What is the source of leak -- waste line or non-waste line? waste line.Was the customer exposed to blood or bodily fluids? yes.Was there any physical harm to the customer as a result of the leak? no.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? unknown.6) was the waste mixed with decontamination/bleach? no.7) was the customer/bd personnel physically in contact with the fluid? yes.8) where did the physical contact of fluid occur? customer in contact with the fluids, but they were wearing their ppe, which consisted of lab coats, gloves, and face-shield to clean up spill.No fluids were on actually contacted on customer's skin or clothes.9) what personal protective equipment was being used during the occurrence? gloves, lab coats, face-shields.10) was there any impact to patient samples due to leak? no.11) was customer/bd personnel harmed/injured? no.

Manufacturer Narrative

H6: investigation summary: scope of issue: the scope of issue is limited to part: (b)(4) spaii and serial number: (b)(6) ¿ problem statement: customer reported: leakage of biohazard ¿ manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from (b)(6) 2019 to date (b)(6) 2020 (rolling 12 months) ¿ complaint trend:there are 15 complaints related to the reported complaint.Date range (date of incident to 12 months back) from (b)(6) 2019 to date (b)(6) 2020 (rolling 12 months) o see attachment for list of complaints: ¿ investigation result / analysis: per fse report: the leak was coming from the wash tower because the waste line was backed up from blockage in the waste pump head assembly.The leak was waste and fluids used for the instrument operations such as sheath, di water and lyse.The fluid was not under any type of pressure.There was no bodily contact or harm to the customer or fse caused by the leak however the leak was not contained within the instrument.Bleach was used to clean and disinfect the instrument and surrounding areas.The clog in the waste pump head was due to cores from the yellow vacutainer caps.The tubes used are bd vacutainer acd solution a #(b)(6).The probe had 1600 piercings and was lot# f164970.Photos are attached to the work order.The blockage was cleared after disassembling the head and flushing with di water.The pump was reassembled and the couplings were replaced to avoid any further cores from going downstream past the filter.The filter was inspected.The instrument was tested and verified as operating to specs.The problem was corrected and there was no further leaking or blockage.¿ service max review: review of related work order #(b)(4).Install date: defective part number: there were no defective parts.Work order notes: o subject / reported: waste leakage.O problem description: clogged waste pump.O cause: clogged waste pump.O work performed: cleaned the waste pump and filters.O solution: cleaned the waste pump and filters.¿ returned sample evaluation: there were no defective parts.¿ manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and pn(b)(4) was reviewed.The instrument met all the manufacturing specifications prior to release.¿ risk analysis: o risk management file part #(b)(4), revision 02 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 clogged waste pump.¿ conclusion: based on the investigation results and the fse report the complaint was confirmed for the waste leakage ¿ capa: (b)(4) in process.

• 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
• MDR Report Key: 10899018
• MDR Text Key: 220726093
• Report Number: 2916837-2020-00273
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• PMA/PMN Number: K131301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

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
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 07/20/2021
• Supplement Dates FDA Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1