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

Catalog Number 641548

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2020

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.Fda device problem code(s):(b)(4).Fda patient problem code(s): (b)(4).

Event Description

It was reported that while using bd facscanto¿ ruo fluid possibly sheath that was under pressure sprayed outside of instrument.There was no report of user impact.The following information was provided by the initial reporter: wet cart is leaking.Customer states that the leak is from the far right pump.The fluid is spraying out of the black metal casing.Customer suspects that it is sheath fluid and not waste.1.Was the leak liquid or air? liquid 2.Was the leak contained within the instrument? not contained 3.Was there spray of fluid under pressure? yes, customer stated the liquid sprayed out of the pump 4.What was the fluid that leaked? unknown 5.Did biohazard leak before or after waste line? unknown 6.Was the waste mixed with decontaminate/bleach? 7.Was the customer/ bd personnel physically in contact with the fluid? yes 8.Where did the physical contact of fluid occur? gloved hand 9.What personal protective equipment (ppe) was being used during the occurrence? customer was wearing gloves and lab coat 10.Was there any impact to patient samples due to leak? no 11.Was customer/ bd personnel harmed/ injured? no is instrument assurity linc enabled? n customer problem: wet cart is leaking.Customer states that the leak is from the far right pump.The fluid is spraying out of the black metal casing.Customer suspects that it is sheath fluid and not waste.Steps taken with customer/troubleshooting: checked if it was a loose fitting that was leaking.Customer stated that it was the pump that was leaking.Next steps (if necessary): dispatch are you using this product for clinical diagnostic test? n were erroneous results reported and used to treat a patient? n was there any injury or potential injury? n leak (if yes explain)? yes, the customer 1.Was the leak contained within the instrument? no, leaked out the bottom of the wet cart.2.Was the leak in a customer accessible location? yes, when the back panel was opened.3.What was the fluid that leaked? unknown, suspect sheath.4.What is the source of leak -- waste line or non-waste line? suspect non-waste 5.Was the customer exposed to blood or bodily fluids? n 6.Was there any physical harm to the customer as a result of the leak n.

Manufacturer Narrative

After further review mfr#2916837-2020-00332 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.

Event Description

It was reported that while using bd facscanto¿ ruo fluid possibly sheath that was under pressure sprayed outside of instrument.There was no report of user impact.The following information was provided by the initial reporter: wet cart is leaking.Customer states that the leak is from the far right pump.The fluid is spraying out of the black metal casing.Customer suspects that it is sheath fluid and not waste.1.Was the leak liquid or air? liquid 2.Was the leak contained within the instrument? not contained 3.Was there spray of fluid under pressure? yes, customer stated the liquid sprayed out of the pump 4.What was the fluid that leaked? unknown 5.Did biohazard leak before or after waste line? unknown 6.Was the waste mixed with decontaminate/bleach? 7.Was the customer/ bd personnel physically in contact with the fluid? yes 8.Where did the physical contact of fluid occur? gloved hand 9.What personal protective equipment (ppe) was being used during the occurrence? customer was wearing gloves and lab coat 10.Was there any impact to patient samples due to leak? no 11.Was customer/ bd personnel harmed/ injured? no is instrument assurity linc enabled? n customer problem: wet cart is leaking.Customer states that the leak is from the far right pump.The fluid is spraying out of the black metal casing.Customer suspects that it is sheath fluid and not waste.Steps taken with customer/troubleshooting: checked if it was a loose fitting that was leaking.Customer stated that it was the pump that was leaking.Next steps (if necessary): dispatch are you using this product for clinical diagnostic test? n were erroneous results reported and used to treat a patient? n was there any injury or potential injury? n leak (if yes explain)? yes, the customer 1.Was the leak contained within the instrument? no, leaked out the bottom of the wet cart.2.Was the leak in a customer accessible location? yes, when the back panel was opened.3.What was the fluid that leaked? unknown, suspect sheath.4.What is the source of leak -- waste line or non-waste line? suspect non-waste 5.Was the customer exposed to blood or bodily fluids? n 6.Was there any physical harm to the customer as a result of the leak n.

• Brand Name: BD FACSCANTO RUO
• Type of Device: NA
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 11097797
• MDR Text Key: 226004306
• Report Number: 2916837-2020-00332
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/18/2021

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: 641548
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1