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

Catalog Number 343022

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/09/2023

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.

Event Description

It was reported that while using the bd facscalibur¿ that there was a leak.The following information was provided by the initial reporter: liquid leaking from the bottom of the sheath drawer.

Event Description

It was reported that while using the bd facscalibur¿ that there was a leak.The following information was provided by the initial reporter: liquid leaking from the bottom of the sheath drawer.

Manufacturer Narrative

Bdb has monitored its mdr reporting, and after review, has determined through valid data that: (1) the relevant malfunctions have not caused or contributed to further deaths or serious injuries for two years, and (2) the likelihood of another death or serious injury as a result of the relevant malfunctions is remote.Accordingly, bdb has amended its mdr reporting guidelines to discontinue further presumptive reporting of malfunctions associated with liquid leakage and splash complaints.Mfr.# 2916837-2023-00039 was filed under previous guidance and is now corrected to be a non-reportable event.The aforementioned amendment to the bdb mdr reporting guidelines was based on the following rationale: to evaluate the impact of this proposed change, an assessment of the complaint and adverse event reporting history was performed for malfunctions associated with serious injuries or deaths related to liquid leakage and splash events.The assessment confirms there have been no reports of serious injury or death related to liquid leakage or splash events for the last two years ((b)(6) 2020 thru (b)(6)2022).We also note that the likelihood of another death or serious injury as a result of the relevant malfunctions is remote.Specifically, a liquid leakage or splash of a chemical or potentially biohazardous fluid would be readily apparent to the user and is unlikely to come in contact with eyes, mouth, other mucous membrane, and non-intact skin, or cause parenteral contact with blood or other potentially infectious materials.Users are also instructed to follow universal precautions including wearing ppe per the products user documentation, and the requirements in the osha bloodborne pathogen guideline.As such, the risk of serious injury or death occurring related to malfunctions causing liquid leakage or splash events would be improbable.

• Brand Name: BD FACSCALIBUR¿
• 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: 16388834
• MDR Text Key: 309762028
• Report Number: 2916837-2023-00039
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 343022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2017
• 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