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

Catalog Number 662383

Device Problem Leak/Splash (1354)

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

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The event described occurred on an ruo 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.

Event Description

It was reported that while using the bd facslyric¿ that liquid was "spryaing all over the place".The following information was provided by the initial reporter: as per, wo-02716403, failing p2 pump.During training they had an issue with the long clean where their bypass tubing was kinked and caused a back up in the plenum making it overflow.Customers words were that at one point liquid was "spraying all over the place".There is clear signs of liquid on most of the motors, but the rest of the parts seem to have very little liquid.Replaced p2 pump continued to fail so ordered a new bucket.First bucket ordered was inoperable and the second bucket solved the issue.Passed pqc and abort count checks.

Event Description

It was reported that while using the bd facslyric¿ that liquid was "spryaing all over the place".The following information was provided by the initial reporter: as per wo-02716403, failing p2 pump.During training they had an issue with the long clean where their bypass tubing was kinked and caused a back up in the plenum making it overflow.Customers words were that at one point liquid was "was spraying all over the place".There is clear signs of liquid on most of the motors, but the rest of the parts seem to have very little liquid.Replaced p2 pump, continued to fail, ordered a new bucket.First bucket ordered was inoperable, second bucket solved the issue.Passed pqc and abort count checks.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 2916837-2022-00368 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.H3 other text : see h.10.

• Brand Name: BD FACSLYRIC¿
• Type of Device: BD FACSLYRIC¿ RUO
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16030186
• MDR Text Key: 308487887
• Report Number: 2916837-2022-00368
• Device Sequence Number: 1
• Product Code: OYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 662383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2020
• 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