MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS SAMPLE PREP ASSISTANT II; STATION, PIPETTING DILUTING CLINICAL USE

Catalog Number 337170

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 10/02/2020

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.(b)(4).

Event Description

It was reported that while using bd facs sample prep assistant ii waste leaked outside of instrument prior to being decontaminated.The following information was provided by the initial reporter: it was reported that the facs has a sample overflow issue.Was the leak liquid or air? liquid was the leak contained within the instrument? no (if not contained) was there spray of fluid under pressure? no spray or pressure, just dripping.What was the fluid that leaked? waste what is the source of leak ¿ before waste tank or after waste tank? before waste tank.(if waste line) ¿ was waste mixed with bleach or decontaminate? no.Was waste mixed with bleach or decontaminate? no.Was the customer/bd personnel physically in contact with the fluid? no.Was the leak in a customer accessible location? yes.

Event Description

It was reported that while using bd facs sample prep assistant ii waste leaked outside of instrument prior to being decontaminated.The following information was provided by the initial reporter: it was reported that the facs has a sample overflow issue.1.Was the leak liquid or air? liquid.2.Was the leak contained within the instrument? no.2b-(if not contained) was there spray of fluid under pressure? no spray or pressure, just dripping.4.What was the fluid that leaked? waste.5.What is the source of leak ¿ before waste tank or after waste tank? before waste tank.5b (if waste line) ¿ was waste mixed with bleach or decontaminate? no.6.Was waste mixed with bleach or decontaminate? no.7.Was the customer/bd personnel physically in contact with the fluid? no.8.Was the leak in a customer accessible location? yes.

Manufacturer Narrative

H6: investigation summary.Customer complained the wash station overflowed at the end of the run.Run spa for 2 hours without issue.Perform lyse dispense and measure volume, cv= 1.1212%, ok.Replace filter and quick connector (from customer stock) + replace waste connector on tank tray and waste line going to drain.Unable to replicate the issue.Review of the dhr for serial number: t0310 and pn337170 was reviewed.The instrument met all the manufacturing specifications prior to release.Based on the investigation results and the fse report the complaint was unconfirmed h3 other text : see h10.

• Brand Name: BD FACS SAMPLE PREP ASSISTANT II
• Type of Device: STATION, PIPETTING DILUTING CLINICAL USE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES; 2350 qume drive; san jose CA 95131
• MDR Report Key: 10764116
• MDR Text Key: 246425664
• Report Number: 2916837-2020-00219
• Device Sequence Number: 1
• Product Code: JQW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 337170
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 02/16/2021
• Supplement Dates FDA Received: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1