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

Model Number 342975

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/20/2022

Event Type  malfunction  

Event Description

It was reported by the customer that bd facscalibur¿ flow cytometer had waste leakage without bleach not contained (outside instrument).There was one occurrence in this event with no patient impact.The following information was provided by the customer: facscalibur - unable to flush syringe outer tube clinical use." was the leak liquid or air? (if liquid/both, go to question #2.If air, no further questions required.): liquid.Was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.): not contained.Was there spray of liquid? (if yes, describe the liquid that sprayed then go to question #7.If no, type "no" in the text box then go to question #4): no.4 what was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/unknown, go to question #5): the liquid waste 5 did biohazard leak before or after waste line? (if before waste line or unknown, go to question #7.If after waste line, go to question #6): before waste line 7 was the customer/bd personnel physically in contact with the fluid? (if yes, go to question #8.If no, no further questions required.) physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: no.

Manufacturer Narrative

Medical device expiration date: unknown.Initial reporter phone number: (b)(6).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 summary investigation summary: scope of issue: the scope of issue is only limited to facscalibur cytometer 4 color basic ivd, part # 342975, serial # (b)(6).Problem statement: customer reported complaint regarding waste leak not contained within the instrument.Manufacturing defect trend: there are zero qns (quality notifications) related to the reported issue.Date range from 20jun2021 to 20jun2022.Complaint trend: there are 11 complaints related to the reported problem, date range from 20jun2021 to 20jun2022.Manufacturing device history record (dhr) review: dhr part #342975 serial # (b)(6), file # 342975-342975-e34297502526-100172700-14, 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 waste leak not contained within the instrument was a worn waste tubing line.The customer reported that they were unable to flush the injection needle external tube.The field service representative (fsr) confirmed that the root cause of waste leak was the waste tubing line and replaced it.After the replacement, the instrument was performing as intended with no further leaks.No parts were requested for evaluation as tubing is not returnable and was discarded.Although the leak was waste, there was no skin contact and no user was harmed or injured.Users should wear proper ppe (personal protective equipment) especially while handling biological waste as stated in the calibur¿s ifu (instructions for use).Proper daily and monthly cleaning procedures can be found in there as well.Information can be found in the bd facscalibur¿ instructions for use, 23-12911-02 rev.01/vers.A, page 173 (maintenance).The safety risk of this hazard has been identified to be within the acceptable level.Service max review: review of related work order #:(b)(4), case # (b)(4) install date: 21aug2014 defective part number: n/a work order notes: subject: pi-342975-facscalibur - unable to flush the needle outer tube.Problem description: facscalibur - unable to flush the injection needle external tube clinically using zhu wenlong.Work performed: replace the leaking pipeline, the instrument is normal.Cause: leakage in waste line.Solution: replace the leaking pipeline, the instrument is normal returned sample evaluation: a return sample was not requested because replaced part is not returnable and was discarded.Risk analysis: risk management file part # 342973ra, rev.04/vers.D, bd facscalibur product family risk analysis.This file did not contain the appropriate hazards and mitigations, and an ecr has been created to assess additional hazards and their risk levels.Ecr # 500000276425 has been created and will revise the existing document to include causes, mitigations, and risk ratings for failures due to worn waste tubing.Root cause: based on the investigation results the root cause was due to worn waste tubing line.Conclusion: based on the investigation results, the root cause of waste leak not contained within the instrument is a worn waste tubing line.The fsr confirmed the issue and replaced the line.After the repair, the instrument was functioning as expected.No one was harmed or injured, and no further leaks occurred.The safety risk of this hazard has been identified to be within the acceptable level.Supporting document: n/a.

Event Description

It was reported by the customer that bd facscalibur¿ flow cytometer had waste leakage without bleach not contained (outside instrument).There was one occurrence in this event with no patient impact.The following information was provided by the customer: " facscalibur - unable to flush syringe outer tube clinical use." 1 was the leak liquid or air? (if liquid/both, go to question #2.If air, no further questions required.): liquid.2 was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.): not contained.3 was there spray of liquid? (if yes, describe the liquid that sprayed then go to question #7.If no, type "no" in the text box then go to question #4): no.4 what was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/unknown, go to question #5): the liquid waste.5 did biohazard leak before or after waste line? (if before waste line or unknown, go to question #7.If after waste line, go to question #6): before waste line.7 was the customer/bd personnel physically in contact with the fluid? (if yes, go to question #8.If no, no further questions required.) physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: no.

• Brand Name: BD FACSCALIBUR¿ FLOW CYTOMETER
• 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: 15427905
• MDR Text Key: 300789549
• Report Number: 1119779-2022-01193
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 00382903429752
• UDI-Public: 00382903429752
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K923790
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 342975
• Device Catalogue Number: 342975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2014
• 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