MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD FACS¿ LYSE WASH ASSISTANT; STATION, PIPETTING DILUTING CLINICAL USE

Catalog Number	337146
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that erroneous results were obtained on patient samples during use with the bd facs¿ lyse wash assistant.The following information was provided by the initial reporter: the preparer does not lyse the samples correctly and the volume is not correct.Mdr safety checklist -- patient samples (case): 1.Are there erroneous results on patient samples from diagnostic test?(if yes or unknown, go to question #2.If no, no further questions required): yes.2.Was there any delay of treatment due to the issue? unknown.3.If the patient samples were redrawn, was there any change or delay of treatment? no.4.Was there any physical harm/injury to the patient due to the issue?no.5.Provide details ¿ how and to what extent? it was not needed to redraw the patients because there was enough sample to repeat manually the preparation.There was a delay in the diagnosis but at the moment she doesn¿t know if there will be a delay in the treatment.
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office - becton dickinson and company bd biosciences san jose ca, 95131 g.1 - reporting office contact - (b)(6).G.1 - manufacturing site contact - (b)(6).H.6 - imdrf annex f: f26.Investigation summary: based on the complaint trend, defect trend, dhr, risk analysis and service activity review, the issue 'does not lyse the samples correctly' was confirmed, and the potential cause of the unexpected results was determined to be obstructions in the wash arm.The fse disassembled the arm, cleaned, and lubricated it and subsequent testing showed the instrument was functioning as expected.No one was harmed or injured, and no patients were diagnosed or treated based on any erroneous results.The safety risk of this hazard has been identified to be within the acceptable level.Complaints received for this device will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that erroneous results were obtained on patient samples during use with the bd facs¿ lyse wash assistant.The following information was provided by the initial reporter: the preparer does not lyse the samples correctly and the volume is not correct mdr safety checklist -- patient samples (case): 1.Are there erroneous results on patient samples from diagnostic test? (if yes or unknown, go to question #2.If no, no further questions required): yes.2.Was there any delay of treatment due to the issue? unknown.3.If the patient samples were redrawn, was there any change or delay of treatment? no.4.Was there any physical harm/injury to the patient due to the issue? no.5.Provide details ¿ how and to what extent? it was not needed to redraw the patients because there was enough sample to repeat manually the preparation.There was a delay in the diagnosis but at the moment she doesn¿t know if there will be a delay in the treatment.

• Brand Name: BD FACS¿ LYSE WASH ASSISTANT
• Common Device Name: STATION, PIPETTING DILUTING CLINICAL USE
• 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: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 17477855
• Report Number: 2916837-2023-00161
• Device Sequence Number: 19456287
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2024

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
• Operator of Device: Other
• Device Catalogue Number: 337146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown