MAUDE Adverse Event Report: TRIPATH IMAGING, INC BD TOTALYS¿ MULTIPROCESSOR CONSUMABLES KIT; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Model Number 491453

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

D4.Medical device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H4.Device manufacture date: unknown.

Event Description

It was reported that 14 bd totalys¿ multiprocessor consumables kit had missing or blank labels before use.The following information was provided by the initial reporter, translated from japanese: according to the customer's report, 13 tubes with blank labels and one tube without a label were found before usage.

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: 2023-06-1620.H.6.Investigation summary: the customer complained about labels on 13 centrifuge tubes from an unknown lot of catalog number 491453 (totalys multiprocessor consumables kit) not containing print.Additionally, one centrifuge tube was missing a label.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 20u4721.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 20u4721 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'.Three photographs were provided.None of the pictures show any tubes with blank print or missing labels.Instead, the first one shows a tube with a printed label beside the bag label showing the lot number, the 2nd picture shows a picture of a tube with a printed label, and the 3rd picture shows a close-up picture of the cone of the tube with a black speck on it.However, the 13 tubes with no label print and one tube with a missing label were returned to the mebane, nc location for evaluation.The complaint is confirmed.

Event Description

It was reported that 14 bd totalys¿ multiprocessor consumables kit had missing or blank labels before use.The following information was provided by the initial reporter, translated from japanese: according to the customer's report, 13 tubes with blank labels and one tube without a label were found before usage.

• Brand Name: BD TOTALYS¿ MULTIPROCESSOR CONSUMABLES KIT
• Type of Device: PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17225676
• MDR Text Key: 318235920
• Report Number: 3008007472-2023-00007
• 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,Foreign,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: 06/09/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1