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

Catalog Number 663029

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

The event described occurred on an ce-ivd instrument, but it is considered to be substantially similar to the legally u.S.Marketed ivd version of the instrument.The ivd instrument¿s 510k has been reported.Device evaluated by mfr: 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 the bd facslyric¿ that there was a leak.The following information was provided by the initial reporter: the customer reports that the mtlp drips when the instrument performs a sit flush.

Manufacturer Narrative

Awareness date has been updated from 12/14/2022 to 12/28/2022.

Event Description

It was reported that while using the bd facslyric¿ that there was a leak.The following information was provided by the initial reporter: the customer reports that the mtlp drips when the instrument performs a sit flush.

• Brand Name: BD FACSLYRIC¿
• Type of Device: NA
• 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: 16396625
• MDR Text Key: 310077254
• Report Number: 2916837-2023-00041
• Device Sequence Number: 1
• Product Code: OYE
• UDI-Device Identifier: 00382906630292
• UDI-Public: (01)00382906630292
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K201814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 663029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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