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	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that carryover was observed on patient samples during use with the bd facs¿ lyse wash assistant.The following information was provided by the initial reporter: 1.Was there any carryover of patient samples? yes, this was reported by the customer and the reason for the pirs, but for the moment it is unclear if it is related to lwa, bd facslyric or preparation / internal reagent contamination.2.Was there any contamination of patient samples? no if this is a different question to question 3 (if contamination doesn´t mean detected carried over cells).3.Are there erroneous results on patient samples for diagnostic test? can be answered with ¿no¿ because they noticed it during their standard plausibility checks.4.Was there any delay of treatment due to the issue? no.5.If patient samples were redrawn, was there any change or delay of treatment? no.6.Was there any physical harm/injury to the patient due to the issue? no.7.What is the current medical status? n.A.The sample is not separated, the blood is dark red.
Additional Manufacturer Narrative
D.4.Medical device expiration date: na.E.1.Initial reporter phone#: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that carryover was observed on patient samples during use with the bd facs¿ lyse wash assistant.The following information was provided by the initial reporter: 1.Was there any carryover of patient samples? yes, this was reported by the customer and the reason for the pirs, but for the moment it is unclear if it is related to lwa, bd facslyric or preparation / internal reagent contamination.2.Was there any contamination of patient samples? no if this is a different question to question 3 (if contamination doesn´t mean detected carried over cells) 3.Are there erroneous results on patient samples for diagnostic test? can be answered with ¿no¿ because they noticed it during their standard plausibility checks 4.Was there any delay of treatment due to the issue? no.5.If patient samples were redrawn, was there any change or delay of treatment? no.6.Was there any physical harm/injury to the patient due to the issue? no.7.What is the current medical status? n.A.The sample is not separated, the blood is dark red.
Additional Manufacturer Narrative
The following fields have been updated with corrected information: g.1 - reporting office contact - fahmy razak.G.1 - manufacturing site contact - fahmy razak.G.1 - reporting office- becton dickinson and company bd biosciences h6.Investigation summary: based on the investigation results, the reported issue of the sample is not separated was not confirmed.Investigation results that were performed on the indicated failure mode were the following: the potential cause was undetermined as the customer resolved the issue on their own and a field service dispatch was not needed.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.The manufacturing device history record (dhr) was reviewed and the instrument met all the manufacturing specifications prior to release.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.

• 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: 17745959
• Report Number: 2916837-2023-00180
• Device Sequence Number: 5460989
• Product Code: JQW
• UDI-Device Identifier: 00382903371464
• UDI-Public: 00382903371464
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2024

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: 08/30/2023
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• 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