MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSMELODY

Catalog Number 661765

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Initial reporter phone #: (b)(6).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 while using bd facsmelody¿ waste leakage occurred outside of instrument.No patient/user impact was reported.The following information was provided by the initial reporter, translated from (b)(6) to english: it is also slightly damp on the outside of the sample chamber cover.At this time it is not possible to determine the nature of the liquid, but even if it is the sample, no hazardous material was used, so there is no danger to the customer.

Event Description

It was reported that while using bd facsmelody¿ waste leakage occurred outside of instrument.No patient/user impact was reported.The following information was provided by the initial reporter, translated from german to english: it is also slightly damp on the outside of the sample chamber cover.At this time it is not possible to determine the nature of the liquid, but even if it is the sample, no hazardous material was used, so there is no danger to the customer.

Manufacturer Narrative

The awareness date for type of fluid leaking.Was 2021-01-05 as it was unknown what was leaking until then.At the time of mfr report # 2916837-2020-00337, the type of fluid was not confirmed.G.4.Date received by manufacturer: 2021-01-05.

Event Description

It was reported that while using bd facsmelody¿ waste leakage occurred outside of instrument.No patient/user impact was reported.The following information was provided by the initial reporter, translated from german to english: it is also slightly damp on the outside of the sample chamber cover.At this time it is not possible to determine the nature of the liquid, but even if it is the sample, no hazardous material was used, so there is no danger to the customer.

Manufacturer Narrative

After further review mfr#2916837-2020-00337 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 FACSMELODY
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11098824
• MDR Text Key: 242894509
• Report Number: 2916837-2020-00337
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 661765
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1