MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD MULTI-CHECK CD4 LOW CONTROL; COUNTER, DIFFERENTIAL CELL

Catalog Number	340914
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a labeling issue with bd multi-check cd4 low control.The following information was provided by the initial reporter: multi-check cd4 low control product (#340914 bm0823l) box contains another product, multi-check control (#340911; bm0823n) tube, so complaints are coming in.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.G.5.Pma / 510(k)#: k150815.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 there was a labeling issue with bd multi-check cd4 low control.The following information was provided by the initial reporter: multi-check cd4 low control product (#340914 bm0823l) box contains another product, multi-check control (#340911; bm0823n) tube, so complaints are coming in.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted report 2243072-2023-01523 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.H3 other text : see h.10.

• Brand Name: BD MULTI-CHECK CD4 LOW CONTROL
• 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; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17644382
• Report Number: 2243072-2023-01523
• Device Sequence Number: 14850590
• Product Code: GKZ
• UDI-Device Identifier: 00382903409143
• UDI-Public: 00382903409143
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 09/08/2023

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: 09/02/2023
• Device Catalogue Number: 340914
• Device Lot Number: BM0823L
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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