MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES BD TRUCOUNT TUBES; COUNTER, DIFFERENTIAL CELL

Model Number	340334
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple 510k numbers reported to be involved.The information for the additional 510k is as follows: pma / 510(k)#: k090967, k980858, k971205, k971110, k970326, k970742, and k071143.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 the lot # on 12 bags is different than the lot # on the shipper with a bd trucount¿ tubes.The following information was provided by the initial reporter, translated from chinese to english: the batch of the product packaging box does not match the batch of the inner bag.
Additional Manufacturer Narrative
After further evaluation of the complaint, it has been determined that the previously submitted mfr report # 2916837-2021-00306 was sent in error.A photo provided by the customer illustrate a box with the batch 1112420 that correspond to the batch number for the kit of material 340344 and the pouch with the reference batch 21087 that corresponds to the batch number for the semifinished material.The illustration represents how bd manufacture and pack finished materials.Therefore, this is not considered to be a reportable malfunction.
Event or Problem Description
It was reported that the lot # on 12 bags is different than the lot # on the shipper with a bd trucount¿ tubes.The following information was provided by the initial reporter, translated from chinese to english: the batch of the product packaging box does not match the batch of the inner bag.

• Brand Name: BD TRUCOUNT TUBES
• 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: 12160563
• Report Number: 2916837-2021-00306
• Device Sequence Number: 11656963
• Product Code: GKZ
• UDI-Device Identifier: 00382903403349
• UDI-Public: 00382903403349
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K970836
• 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): 08/05/2021

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: 03/31/2023
• Device Model Number: 340334
• Device Catalogue Number: 340334
• Device Lot Number: 1112420
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1