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	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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 while using the bd totalys multiprocessor consumables kit, 480 that there were missing labels.The following information was provided by the initial reporter: this is a report about a labeling issue.According to the customer¿s information, a centrifuge tube without a label was found before usage.
Event or Problem Description
It was reported that while using the bd totalys multiprocessor consumables kit, 480 that there were missing labels.The following information was provided by the initial reporter: this is a report about a labeling issue.According to the customer¿s information, a centrifuge tube without a label was found before usage.
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: 2023-02-21.H.6.Investigation summary: the customer complained about a centrifuge tube from an unknown lot number of catalog 491453 missing a 2d barcode label.Material 500024399 is a purchased subcomponent that is used in catalog 491453.The customer communicated that the lot number of 500024399 that was missing the 2d barcode was supplier lot number 20u1321.A dhr 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.A retain analysis could not be conducted because retain samples of this product are not kept by bd.Two pictures were provided by the customer.One of the pictures contains a picture of one tube without the label and the 2nd picture is a picture of the bag label.The unlabeled tube and bag label were also returned to the mebane, nc location.The complaint is confirmed.Bd apologizes for the inconvenience caused by the issue.

• 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 ; 8448235433
• MDR Report Key: 16493102
• Report Number: 1119779-2023-00235
• Device Sequence Number: 6239903
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 02/08/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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