MAUDE Adverse Event Report: TRIPATH IMAGING, INC D CUBE CONSUMABLES KIT 480; CENTRIFUGE TUBES, 15 ML

Catalog Number 491460

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 02/24/2022

Event Type  malfunction  

Event Description

It was reported that bd centrifuge tubes with 2d barcode was missing the label.The following information was provided by the initial reporter: " according to the customer's report, the label of centrifuge tube was missing.".

Manufacturer Narrative

Investigation summary: the problem reported by the customer was one (1) centrifuge tube (material 500024399) of an unknown lot number not containing the 2d barcode label.Centrifuge tube part number 500024399 is used during the cell enrichment of cells prior to the transfer and staining of the cells on the bd automated staining system.When used, the sample is transferred from the vial to the tube, resulting in a cell pellet after the centrifugation process.Each tube contains a 2-dimensional barcode that is used to support automated chain of custody for the specimen.The centrifuge tubes are polypropylene plastic injection molded parts purchased from an approved bd supplier.The supplier applies the 2-dimensional barcode on the tubes as well as the bd labeling on the outside of the bags.When received into the bd mebane, (b)(4) facility they are subjected to incoming qc inspection using an ansi, single sampling, level i, at an aql of 1.0%.No lot number was provided; therefore, a review of the inspection documentation could not be performed.However, the tubes would have had to pass inspection to be used as a subcomponent in kitting.No samples were returned for evaluation and no photographs were provided.Additionally, a retain analysis could not conducted because retain samples are not kept by bd.Therefore, the complaint could not be confirmed.A lot number was not provided, therefore a review of the complaint history review by lot number could not be performed.However, a 12-month complaint review was performed and identified that bd has received one (1) prior complaint for centrifuge tube material number 500024399 missing the tube labels.Bd performs regular trending to determine if a corrective and preventative action (capa) is required, and as of this time the threshold for a capa has not been reached.Bd will continue to monitor and evaluate trends.

Event Description

It was reported that bd centrifuge tubes with 2d barcode was missing the label.The following information was provided by the initial reporter: according to the customer's report, the label of centrifuge tube was missing.

Manufacturer Narrative

This mdr is to correct mfr.Report # (b)(4) to a not reportable event.The complaint was initially logged against a component of the kit but should have been logged against the kit itself.This product is not sold within the us and bd does not sell a similar product within the us and/or it is not a registered medical device in the us.This complaint is not mdr reportable.There was no report of serious injury, medical intervention, or reportable device malfunction.The following fields have been updated.D1: medical device brand name: d cube consumables kit 480.D4: catalog: 491460.D.4.Lot: 1293770.D.4.Exp date: 31oct2023.D.4.Udi # (b)(4).H4: device manufacture date: 20-oct-2023.

• Brand Name: D CUBE CONSUMABLES KIT 480
• Type of Device: CENTRIFUGE TUBES, 15 ML
• 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 ; 8015296192
• MDR Report Key: 13870527
• MDR Text Key: 288176599
• Report Number: 3008007472-2022-00003
• Device Sequence Number: 1
• Product Code: MKQ
• 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: 09/08/2023

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 Expiration Date: 10/31/2023
• Device Catalogue Number: 491460
• Device Lot Number: 1293770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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