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

Model Number 491453

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  malfunction  

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 317137919
• Report Number: 3008007472-2023-00005
• Device Sequence Number: 1
• Product Code: MKQ
• UDI-Device Identifier: 00382904914530
• UDI-Public: 00382904914530
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P970018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1