MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS LWA; STATION, PIPETTING DILUTING CLINICAL USE

Catalog Number 337408

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

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 that during use with a bd facs¿ lwa there were low sample counts on patient samples.There was no reported patient impact.The following information was provided by the initial reporter: sample count low.Please confirm if the low counts were observed on patient samples that were intended for clinical use,yes.If so, was there any impact to the patient? no.Were samples redrawn? no.Was there any delay in treatment? no.

Event Description

It was reported that during use with a bd facs¿ lwa there were low sample counts on patient samples.There was no reported patient impact.The following information was provided by the initial reporter: sample count low please confirm if the low counts were observed on patient samples that were intended for clinical use.Yes.If so, was there any impact to the patient? no.Were samples redrawn? no.Was there any delay in treatment? no.

Manufacturer Narrative

After further review mfr#2916837-2020-00197 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 LWA
• Type of Device: STATION, PIPETTING DILUTING CLINICAL USE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10703532
• MDR Text Key: 239997847
• Report Number: 2916837-2020-00197
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

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: 337408
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 06/15/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other