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

Model Number	340911
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter e-mail: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Initial reporter phone #: (b)(6).
Event or Problem Description
It was reported that while using the bd¿ multi-check that there was a label issue.The following information was provided by the initial reporter: tube has no label (see attached picture).
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 investigation summary: based on the investigation results, the reported issue of a missing tube label was confirmed.Investigation results that were performed on the indicated failure mode were the following: ¿ photos were returned including views of tube and carton.¿ routine inspection of retained samples at bdb was performed; no labels missing.¿ bhr review of batch supplier quality control documentation was performed.¿ supplier performed an investigation #2023-1174-1.¿ assembly oversight in the 100% inspection of filled and labeled vials was identified as potential cause.¿ no other related complaint reports were received for this product in the previous 12 months.¿ a replacement vial was provided to the customer.¿complaints received for this device and reported condition 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.H3 other text : see h.10.
Event or Problem Description
It was reported that while using the bd¿ multi-check that there was a label issue.The following information was provided by the initial reporter: tube has no label.

• Brand Name: BD¿ MULTI-CHECK
• Common Device Name: 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: fahmy razak - mdr ; 2350 qume drive; san jose, CA 95131 ; 4089542435
• MDR Report Key: 16064713
• Report Number: 2916837-2022-00375
• Device Sequence Number: 6686134
• Product Code: GKZ
• UDI-Device Identifier: 00382903409112
• UDI-Public: 00382903409112
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K961610
• 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): 03/05/2024

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 Expiration Date: 01/02/2023
• Device Model Number: 340911
• Device Catalogue Number: 340911
• Device Lot Number: BM1222N
• 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: 12/05/2022
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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