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

Catalog Number	340912
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.5.Pma / 510(k)#: k961610.G.5.Pma / 510(k )#: k982231.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 the label was missing from the bd multi-check¿.The following information was provided by the initial reporter: no reference values provided.No assay values and expected ranges were provided with the product, customer is asking for these.Could you please clarify if part of the label was missing or if the information is incorrect on the label? yes that is correct, this was missing from the product.
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)(4).G.1 - manufacturing site contact - (b)(4).H.6 - annex f annex code - f26.H.6 investigation summary: ¿ based on the investigation results, the reported issue of missing labeling was confirmed.Investigation results that were performed on the indicated failure mode were the following: ¿ no photo was provided with the report, which was submitted for a missing product information flyer.¿ retained kits were visually inspected including the product information flyer.¿ bhr documentation for 340912-bm0623n was reviewed at bdb and by the supplier during the execution of supplier corrective action.¿ the potential cause was identified as lack of training and inadequate line clearance pertaining to the manufacturing process.Issue was resolved by providing customer the missing insert assay values.¿ 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.
Event or Problem Description
It was reported that the label was missing from the bd multi-check¿.The following information was provided by the initial reporter: no reference values provided no assay values and expected ranges were provided with the product, customer is asking for these.Could you please clarify if part of the label was missing or if the information is incorrect on the label? yes that is correct, this was missing from the product.

• 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: 17401273
• Report Number: 2916837-2023-00151
• Device Sequence Number: 20322386
• Product Code: GKZ
• UDI-Device Identifier: 00382903409129
• UDI-Public: 00382903409129
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: SEE H.10
• 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): 04/29/2024

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: 07/02/2023
• Device Catalogue Number: 340912
• Device Lot Number: BM0623N
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2023
• 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