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

Catalog Number 663029

Device Problem Contamination (1120)

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

Event Date 01/24/2022

Event Type  malfunction  

Event Description

It was reported that carryover occured while using bd facslyric¿.There was no report of patient impact.The following information was provided by the initial reporter: 663029 - facslyric 3l12c instrument ceivd - carry over issue.

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.

Manufacturer Narrative

H6: investigation summary scope of issue: the scope of issue is only limited to facslyric 3l12c instrument ceivd, part # 663029, serial # (b)(6).Problem statement: customer reported a complaint regarding the instrument producing high carry over.Manufacturing defect trend: there are 0 qns (quality notifications) related to the reported issue.Date range from 24jan2021 to date 24jan2022.Complaint trend: there are 5 complaints related to the issue of high carryover; date range from 24jan2021 to date 24jan2022.Manufacturing device history record (dhr) review: dhr part #663029 serial # (b)(6), file #663029-663029-r663029000331-107428133-21, 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 carryover could not be determined.The customer had initially reported that two of their instruments were exhibiting high carryover between samples and wanted the other instrument validated first.The scheduled field service waiting on information from the customer that never came and thus an email was sent informing them of the case cancellation.The customer did not respond further and no work was performed on the instrument at this time.No parts were requested for evaluation as there was no repair performed.Although the unexpected results were from patient samples for clinical use, no patient was treated nor harmed by incorrect results.The results were captured prior to any diagnosis decision and was reported to bd as not expected.There was no delay in patient treatment due to any unexpected results.Proper daily and monthly cleaning procedures can be found under ¿maintenance¿ in the user guide; bd facslyric¿ clinical system instructions for use, #23-19938-02 rev.1/vers.A.The safety risk is moderate, s3, and there was no impact to patient health or safety.Service max review: review of related work order #: (b)(4), case # 01577503 install date: 14sep2021 defective part number: n/a work order notes: subject / reported: 663029 - facslyric 3l12c instrument ceivd - carry over issue problem description: 663029 - facslyric 3l12c instrument ceivd - carry over issue work performed: n/a cause: n/a solution: n/a returned sample evaluation: a return sample was not requested because no parts were replaced.Risk analysis: risk management file part # 10000063058ra, rev.06/vers.Z, bd facslyric system risk analysis was reviewed.No new hazards have been identified and the current mitigations are sufficient.Hazard(s) identified? ¿yes ¿no azure id: 89236 id: libivd-ra-256 3.1.34 reg status: ivd; ruo hazard: incorrect data.Source: flow cell fmea cause: tubing or port detail diameters at spec extremes, causing misalignment.Harmful effects: 1 unacceptable carryover 2 potential incorrect results risk control: sample carryover testing to confirm the sample carryover level to specifications.Req link (azure id): n/a implementation verification: lsvn-1013-dp sample carryover effectiveness verification: lsvn-1013-dr probability: 1 severity: 3 risk index: 3 residual risk evaluation: a new hazards: none mitigation(s) sufficient yes no.Root cause: based on the investigation results the root cause of the high carryover between sample tests could not be determined.Conclusion: based on the investigation results the root cause of the high carryover between sample tests could not be determined.The customer had initially reported carryover issues on two of their instruments but did not provide the required information in this case nor responded to the cancellation notice.No repair was performed on this instrument at this time.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.The safety risk is moderate, s3, and there was no impact to patient health or safety.H3 other text : see h10.

Event Description

It was reported that carryover occured while using bd facslyric¿.There was no report of patient impact.The following information was provided by the initial reporter: 663029 - facslyric 3l12c instrument ceivd - carry over issue.

• Brand Name: BD FACSLYRIC¿
• 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: 13476637
• MDR Text Key: 287802963
• Report Number: 2916837-2022-00020
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 663029
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2021
• 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