MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 647205; BD FACS¿ SAMPLE PREP ASSISTANT III

Model Number 647205

Device Problem Contamination (1120)

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

Event Date 03/24/2022

Event Type  malfunction  

Manufacturer Narrative

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 while using bd facs¿ sample prep assistant iii carryover between patient samples had occurred.The following information was provided by the initial reporter: "was there carryover between patient samples? yes.Are there erroneous results on patient samples for diagnostic test? no.It seems that the reaction is weak due to the small amount of reagent set in a specific place.The user reports that the same phenomenon occurred in the two samples.It seems that the reaction is weak due to the small amount of reagent set in a specific place.".

Event Description

It was reported that while using bd facs¿ sample prep assistant iii carryover between patient samples had occurred.The following information was provided by the initial reporter: "was there carryover between patient samples?yes.Are there erroneous results on patient samples for diagnostic test? no.It seems that the reaction is weak due to the small amount of reagent set in a specific place.The user reports that the same phenomenon occurred in the two samples.It seems that the reaction is weak due to the small amount of reagent set in a specific place.".

Manufacturer Narrative

H.6.Correction, investigation summary updated from: conclusion - none.To: conclusion: based on the investigation results and the fse¿s report the complaint was unconfirmed for carryover.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.The safety risk is limited, s2, and there was no impact to the patient health or safety.H3 other text : see h.10.

Event Description

It was reported that while using bd facs¿ sample prep assistant iii carryover between patient samples had occurred.The following information was provided by the initial reporter: "was there carryover between patient samples?yes.Are there erroneous results on patient samples for diagnostic test? no.It seems that the reaction is weak due to the small amount of reagent set in a specific place.The user reports that the same phenomenon occurred in the two samples.It seems that the reaction is weak due to the small amount of reagent set in a specific place.".

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: small amount of reagent set in a specific place.Manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 24mar2021 to date 24mar2022 (rolling 12 months).Complaint trend: there are 2 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 24mar2021 to date 24mar2022 (rolling 12 months) investigation result / analysis: per fse report: comments: (treatment) · prime operation check · set food coloring on the antibody.Confirm that it can be dispensed.With the same panel settings as the customer, only r21 has food coloring, others.Set distilled water and dispense.(result) it was confirmed that there was no problem with dispensing from r21.The customer did it on the same panel and there was no problem.Confirmed.Although the unexpected results were from patient samples for clinical use, no patient was treated nor harmed from incorrect results.The results were captured prior to any diagnosis decision and were immediately noticed and retested.There was no delay in patient treatment due to any unexpected results.Service max review: review of related work order# (b)(4).Install date: 12apr2016.Defective part number: there were no defective parts work order notes: subject / reported: reagent not dispensing in one location.Problem description: reagent not dispensing in one location.Cause: undetermined.Could not duplicate the issue.Work performed: verified prime/dispense.Solution: could not duplicate the issue.Returned sample evaluation: there were no 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: 3.1.20.Hazard: ineffective sample prep.Severity: 3.Probability: 1.Risk index: 3.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 undetermined.Could not duplicate the issue h3 other text : see h.10.

• Brand Name: 647205
• Type of Device: BD FACS¿ SAMPLE PREP ASSISTANT III
• 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: 14000556
• MDR Text Key: 289002849
• Report Number: 2916837-2022-00084
• Device Sequence Number: 1
• Product Code: PER
• UDI-Device Identifier: 00382906472052
• UDI-Public: 00382906472052
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2022

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: 03/24/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 04/19/2022; 06/17/2022
• Supplement Dates FDA Received: 04/27/2022; 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2014
• 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