MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCANTO¿; COUNTER, DIFFERENTIAL CELL

Model Number 338960

Device Problem Contamination (1120)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

Event Type  malfunction  

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.(b)(4).

Event Description

It was reported while testing with bd facscanto¿ carryover occurred.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that there is an hts carry over issue.Are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Was there a fluidic leak or spill? no.Was there spray of fluid under pressure? no.Was the leak/spill contained within the instrument? no.Was the leak/spill in a customer accessible location? no.What was the fluid that leaked/spilled? no.What is the source of leak/spill? (waste or non-waste line) no.Was the customer exposed to blood or bodily fluids? no.Was there any physical harm to the customer as a result of the leak? no.

Manufacturer Narrative

H.6.Investigation: ¿ scope of issue: the scope of issue is limited to part: 338960 facscanto ii and serial number: (b)(6).¿ problem statement: customer reported possible carryover issue with the hts ¿ manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 15jan2020 to date 15jan2021 (rolling 12 months).¿ complaint trend: this is the only complaint related to the reported complaint.Date range (date of incident to 12 months back) from 15jun2019 to date 15jun2020 (rolling 12 months).¿ investigation result / analysis: per the phone documentation: 15jan2021: customer reported hts carryover issue.Customer was instructed to do long clean, replace sample line and coupler.18jan2021: contacted customer for status.26jan2021: customer has not verified if hts is working properly.Customer will call back after verifying hts operation.28jan2021: customer reported hts is working properly ¿ service max review: review of related work order #: wo was not issued install date: (b)(6) 2014.Defective part number: there were no defective parts work order notes: o subject / reported: hts carryover issue.O problem description: carryover issue.O cause: not determined.O work performed: cleaned/replaced sample line.O solution: replaced sample line.¿ returned sample evaluation: there were no defective parts.¿ manufacturing device history record (dhr) review: review of the dhr for sn: (b)(6) pn:338960 was reviewed.The instrument met all the manufacturing specifications prior to release.Risk analysis: risk management file part #100264ra, revision 04/version f was reviewed.Hazard(s) identified? yes no.O hazard id: 3.1.17 _ o hazard: disruption.O severity: 1.O probability: 2.O risk index: 2.O implementation: o risk control: acceptable.Mitigation(s) sufficient: yes no.¿ root cause: based on the investigation result, and the fse¿s report the root cause was not determined.¿ conclusion: based on the investigation results and the fse report the complaint was unconfirmed h3 other text : see h.10.

Event Description

It was reported while testing with bd facscanto¿ carryover occurred.There was no report of patient impact.The following information was provided by the initial reporter: it was reported that there is an hts carry over issue.Are you using this product for clinical diagnostic test? yes.Were erroneous results reported and used to treat a patient? no.Was there any injury or potential injury? no.Was there a fluidic leak or spill? no.Was there spray of fluid under pressure? no.Was the leak/spill contained within the instrument? no.Was the leak/spill in a customer accessible location? no.What was the fluid that leaked/spilled? no.What is the source of leak/spill? (waste or non-waste line) no.Was the customer exposed to blood or bodily fluids? no.Was there any physical harm to the customer as a result of the leak? no.

• Brand Name: BD FACSCANTO¿
• Type of Device: COUNTER, DIFFERENTIAL CELL
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11304939
• MDR Text Key: 244361741
• Report Number: 2916837-2021-00047
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903389605
• UDI-Public: 00382903389605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062087
• 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
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 338960
• Device Catalogue Number: 338960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2014
• 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