MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD TOTALYS MULTIPROCESSOR CONSUMABLES KIT, 480

Model Number	491453
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd totalys multiprocessor consumables kit, 480 centrifuge tubes with no labels.The following information was provided by the initial reporter: there were several centrifuge tubes with labels on which no letters were printed.
Event or Problem Description
It was reported that bd totalys multiprocessor consumables kit, 480 centrifuge tubes with no labels.The following information was provided by the initial reporter: there were several centrifuge tubes with labels on which no letters were printed.
Additional Manufacturer Narrative
The following fields have been updated with corrected and/or additional information.D9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-12-21.H.6.Investigation summary: the customer complained about labels on 8 centrifuge tubes from an unknown lot of catalog number 491453 (totalys multiprocessor consumables kit) not containing print.Material 500024399 is a purchased subcomponent that is used in catalog 491453.The customer communicated that the lot number of defective tubes from 500024399 was supplier lot number 20u1321.A device history record review of 491453 could not be performed because a lot number was not provided.However, material 500024399 is a purchased subcomponent that is used in catalog 491453.The centrifuge tubes are polypropylene plastic injection molded parts purchased from an approved bd supplier.The supplier applies a 2-dimensional barcode on the tubes that is used to support automated chain of custody for the specimen.When received into the bd mebane, nc facility they are subjected to incoming qc inspection using an ansi, single sampling, level i, at an aql of 1.0%.A review of the inspection documentation identified that 500024399 lot 20u1321 was received and inspected on two occasions without any issues identified.Additionally, a review of the c of a provided by the supplier identified that each tube provided contained a 2d label with a unique barcode number, and confirmation that each barcode scanned a grade of either 'a' or 'b'.A retain analysis could not be conducted because retain samples of this product are not kept by bd.Three photographs were provided.The first one shows 8 tubes that have no print on the label applied to them.The 2nd picture is a close-up on 4 of the tube labels.The 3rd picture is a picture of the bag label and lot number that the tubes were identified in.Additionally, the 8 tubes and bag label were returned to the mebane, nc location for evaluation.The complaint is confirmed.H3 other text : see h.10.

• Brand Name: BD TOTALYS MULTIPROCESSOR CONSUMABLES KIT, 480
• Common Device Name: NA
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16043491
• Report Number: 1119779-2022-01543
• Device Sequence Number: 6266843
• Product Code: MKQ
• UDI-Device Identifier: 00382904914530
• UDI-Public: 00382904914530
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P970018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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 Model Number: 491453
• Device Catalogue Number: 491453
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 12/23/2022
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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