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	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that when opening bd¿ multi-check package, the product listed was part # 557940.The following information was provided by the initial reporter, translated from (b)(6) to english: when opening the package, the reference 557940 was in it.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report # 2916837-2021-00182 was sent in error.It was discovered that the issue was a shipping/packaging issue and therefore, is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that when opening bd¿ multi-check package, the product listed was part # 557940.The following information was provided by the initial reporter, translated from french to english: when opening the package, the reference 557940 was in it.

• 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
• MDR Report Key: 11681900
• Report Number: 2916837-2021-00182
• Device Sequence Number: 3495079
• Product Code: GKZ
• UDI-Device Identifier: 00382903409112
• UDI-Public: 00382903409112
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 05/02/2021
• Device Model Number: 340911
• Device Catalogue Number: 340911
• Device Lot Number: BM0421N
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1