MAUDE Adverse Event Report: TRIPATH IMAGING, INC BD TOTALYS MULTIPROCESSOR CONSUMABLES KIT; N/A

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	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd totalys multiprocessor consumables kit there was a centrifuge tube missing label information.The following information was provided by the initial reporter: according to the customer's report, there was a centrifuge tube without the label before usage.The lot# of the kit is unknown and the lot# of the centrifuge tube is reported to be 20u2221.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
D10: device available for eval: yes, d10: returned to manufacturer on: 31-may-2023.H.6 investigation summary: the customer complained about a centrifuge tube from an unknown lot number of catalog 491323 missing a 2d barcode label.Material 500024399 is a purchased subcomponent that is used in catalog 491323.The customer communicated that the lot number of 500024399 that was missing the 2d barcode was supplier lot number 20u2221.A dhr review of 491323 could not be performed because a lot number was not provided.However, material 500024399 is a purchased subcomponent that is used in catalog 491323.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 (b)(4).A review of the inspection documentation identified that 500024399 lot 20u2221 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 beside the bag label and the 2nd picture contains just the tube without the label.The unlabeled tube and bag label were also returned to the mebane, nc location.The complaint is confirmed.
Event or Problem Description
It was reported that bd totalys multiprocessor consumables kit there was a centrifuge tube missing label information.The following information was provided by the initial reporter: according to the customer's report, there was a centrifuge tube without the label before usage.The lot# of the kit is unknown and the lot# of the centrifuge tube is reported to be 20u2221.

• Brand Name: BD TOTALYS MULTIPROCESSOR CONSUMABLES KIT
• Common Device Name: N/A
• Manufacturer (Section D): TRIPATH IMAGING, INC; 1022 corporate park drive; mebane NC 27302
• Manufacturer (Section G): TRIPATH IMAGING, INC; 1022 corporate park drive; mebane NC 27302
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17083655
• Report Number: 3008007472-2023-00005
• Device Sequence Number: 17728846
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2023

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: 05/12/2023
• Supplement Date Received by Manufacturer: 08/15/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 08/22/2023
• 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