MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SAMPLE PREP ASSISTANT II; STATION, PIPPETTING DILUTING CLINICAL

Catalog Number 337170

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2021

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 testing patient samples with bd facs sample prep assistant ii the instrument was not dispensing the proper amount of reagent.Results were not reported and there was no patient impact.The following information was provided by the initial reporter: it was reported that the instrument is not dispensing the proper amount of reagent.Patients were not treated and patient results not reported due to the inconsistent data the (b)(6).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.Software version? unknown.Leak (if yes explain)? no.

Event Description

It was reported testing patient samples with bd facs sample prep assistant ii the instrument was not dispensing the proper amount of reagent.Results were not reported and there was no patient impact.The following information was provided by the initial reporter: it was reported that the instrument is not dispensing the proper amount of reagent.Patients were not treated and patient results not reported due to the inconsistent data the spa.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 software version? unknown leak (if yes explain)? no.

Manufacturer Narrative

After further review mfr#2916837-2021-00061 is no longer reportable.This device is for research use only and is not being used for diagnostic testing or patient treatment and is therefore not subject to mdr reporting.

• Brand Name: BD FACS SAMPLE PREP ASSISTANT II
• Type of Device: STATION, PIPPETTING DILUTING CLINICAL
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11378431
• MDR Text Key: 245520855
• Report Number: 2916837-2021-00061
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 06/18/2021

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 Catalogue Number: 337170
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 06/18/2021
• Supplement Dates FDA Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1