MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACSCALIBUR¿; COUNTER, DIFFERENTIAL CELL

Catalog Number 343020

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/13/2021

Event Type  malfunction  

Event Description

It was reported that bd facscalibur¿ was leaking biohazard that was not contained within the instrument.The following information was provided by the initial reporter: " was the leak liquid or air? liquid.Was the leak contained within the instrument? not contained.Was there spray of liquid under pressure? no.What was the fluid that leaked? biohazard.Did biohazard leak before or after waste line? after waste line.Was the waste mixed with decontamination/bleach? no.Was the customer/bd personnel physically in contact with the fluid? no.While removing the bal seal, the whole sip assembly came loose and dropped.This caused a little leakage of liquid from the flow cell.".

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation: ¿ scope of issue: the scope of issue is only limited to facscalibur basic sensor unit, part # 343020, serial # (b)(6).¿ problem statement: customer reported a complaint regarding a leakage of biohazard not contained within the instrument.¿ manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 13 dec 2020 to 13 dec 2021.¿ complaint trend: this is the only complaint related to the issue of a leakage of biohazard not contained within the instrument for this part number within the date range.Date range from 13 dec 2020 to 13 dec 2021.¿ manufacturing device history record (dhr) review: dhr part #343020 serial # (b)(6) , file #01-21219-00, (b)(6) 2 basic calibu, was reviewed.The instrument met all the manufacturing specifications prior to release.¿ investigation result / analysis: the investigation was performed and based on the review of the complaint trend, defect trend, dhr, risk analysis and servicemax, the root cause of the waste leakage was due to user error when performing maintenance on the instrument.The customer reported that while they were attempting to replace the bal seal, the entire sip assembly came loose from the instrument and dropped.This lead to a small leakage from the flowcell before it was reinstalled.The customer noted that facscomp and controls had passed without warning and there was only a slightly increased flowrate.During the remote assistance, the customer reported that the instrument was functioning as expected with no issues and the case was closed.No parts were requested for evaluation as there were no replaced parts.Although the leakage was of a biohazardous material, the customer confirmed that they did not come in contact with the leakage and were not harmed in any way.Additionally, the leakage was not under pressure and thus did not increase the risk of exposure.Proper daily and monthly cleaning and maintenance can help in preventing lowered performance of the system, and instructions on these procedures can be found in the bd facscalibur system user¿s guide, #338183 rev.1/vers.A.The safety risk of this hazard will be evaluated in ecr 500000276425.¿ service max review: review of related work order #: 02249711, case # (b)(4).Install date: 07 oct 1998.Defective part number: n/a.Work order notes: o: subject / reported: 343020 - facscalibur - sip assembly fell from the instrument.O: problem description: customer reports that this morning while removing the bal seal, the whole sip assembly came loose and dropped.This caused a little leakage of liquid from the flow cell.Customer has placed it back and at the moment facscomp and controls have all passed without warning.Customer only noticed a slight increase in the flowrate.O work performed: customer says that the instrument is working fine at the moment.Monitoring.The customer confirmed that the issue is solved.O cause: the sip assembly came loose and dropped.O solution: the issue has been resolved and the instrument is working within specifications.¿ returned sample evaluation: a return sample was not requested because there were no parts replaced.¿ risk analysis: risk management file part # 342973ra, rev.04/vers.D, risk analysis facscalibur prod family was reviewed.This file did not contain the appropriate hazards and mitigations, and an eco has been opened to assess additional hazards and their risk levels.Ecr #500000276425 has been created and will revise the existing calibur risk analysis document to include causes, mitigations, and risk ratings for carryover, erroneous results, and waste exposure.¿ root cause: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a user error.¿ conclusion: based on the investigation results the root cause of the waste leakage not contained within the instrument was due to a user error.The customer reported that while they were removing the baal seal, the sit assembly came loose and dropped from the instrument, resulting in a minor waste leakage from the sit.The customer was reportedly resolved by the customer and the instrument as functioning within specifications with no need for a field service visit.No one was harmed or injured, and no further leaks occurred.The safety risk of this hazard will be evaluated in ecr 500000276425.

Event Description

It was reported that bd facscalibur¿ was leaking biohazard that was not contained within the instrument.The following information was provided by the initial reporter: "1.Was the leak liquid or air? liquid.2.Was the leak contained within the instrument? not contained.3.Was there spray of liquid under pressure? no.4.What was the fluid that leaked? biohazard.5.Did biohazard leak before or after waste line? after waste line.6.Was the waste mixed with decontamination/bleach? no.7.Was the customer/bd personnel physically in contact with the fluid? no.While removing the bal seal, the whole sip assembly came loose and dropped.This caused a little leakage of liquid from the flow cell.".

• Brand Name: BD FACSCALIBUR¿
• Type of Device: COUNTER, DIFFERENTIAL CELL
• 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: 13101950
• MDR Text Key: 283962528
• Report Number: 2916837-2021-00505
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K973483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 343020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2016
• 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