MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSDUET¿ SAMPLE PREP

Catalog Number	663128
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while running bd facsduet¿ sample prep carryover occurred.There was no patient impact.The following information was provided by the initial reporter: there was carry over and contamination of the antibodies from the machine.Are you using this product for clinical diagnostic test? n.Were erroneous results reported and used to treat a patient? n.Was there any injury or potential injury? n.
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that while running bd facsduet¿ sample prep carryover occurred.There was no patient impact.The following information was provided by the initial reporter: there was carry over and contamination of the antibodies from the machine.Are you using this product for clinical diagnostic test? n.Were erroneous results reported and used to treat a patient? n.Was there any injury or potential injury? n.
Additional Manufacturer Narrative
Investigation summary: ¿ scope of issue: the scope of issue is limited to part: 663128 and sn: (b)(6).¿ problem statement: carryover and contamination of the antibodies from machine ¿ carryover.¿ complaint trend: this is the only complaint from 02oct2020 to date 02oct2021 (rolling 12 months).¿ investigation result / analysis: the carry over and contamination of the antibodies from machine was caused by the worn gear in the plate gripper.¿ risk analysis: o risk management file part #10000225098, version h was reviewed.O hazard(s) identified? yes no.Hazard id: 2.1.10.Hazard: contaminated sample.Potential causes: back drip from probes.Harmful effects: incorrect result by cross contamination severity: 3 probability: 1 risk index: 3 implementation verification - stratec test (b)(4): doc #(b)(4).O mitigation(s) sufficient yes no.¿ service max review: review of related work order (b)(4).Work order notes: arrived onsite and performed a preliminary check.Customer reported fatal errors occurring preventing a startup.Found that (1) the plate gripper was drifting down by itself, (2) salt crystal buildup on and around the syringe pump.(3) syringe found to be loose in the threads.Pipetting not working properly due to leaking syringe.Cleaning and tightening syringe resolved the problem.Instrument is functioning properly and has been returned to customer for use.Work performed comments: (1)adjusted the worm gear on the plate gripper.This resolved the drifting down of the plate gripper.(2&3) cleaned and tightened the syringe on the pump and verified that it was not leaking.Startup is now working properly without errors.Leaving call open to monitor.¿ 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.¿ root cause: loose syringe caused the carryover/leakage.¿ conclusion: based on the investigation results and the fse report the complaint was confirmed.H3 other text : see h10.

• Brand Name: BD FACSDUET¿ SAMPLE PREP
• Common Device Name: NA
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12815731
• Report Number: 2916837-2021-00440
• Device Sequence Number: 4962732
• Product Code: OYE
• UDI-Device Identifier: 00382906631282
• UDI-Public: 382906631282
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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
• Operator of Device: Other
• Device Catalogue Number: 663128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown