MAUDE Adverse Event Report: TRIPATH IMAGING, INC BD D-CUBE¿ CONSUMABLES KIT; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Catalog Number 491460

Device Problem Missing Information (4053)

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

Event Date 01/18/2022

Event Type  malfunction  

Event Description

It was reported that 2 tubes in the bd d-cube¿ consumables kit did not have labels on them.There was no report of user or patient impact.The following information was provided by the initial reporter, translated from (b)(6): "this is a report about a labeling issue of the centrifuge tubes according to the customer¿s report, there were tubes without a label.".

Manufacturer Narrative

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

Event Description

It was reported that 2 tubes in the bd d-cube¿ consumables kit did not have labels on them.There was no report of user or patient impact.The following information was provided by the initial reporter, translated from japanese: "this is a report about a labeling issue of the centrifuge tubes according to the customer¿s report, there were tubes without a label.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 02-feb-2022.H6: investigation: the problem reported by the customer was two (2) centrifuge tubes (material 500024399) of an unknown lot number not containing the 2d barcode labels.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, nc 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.Two pictures were provided by the customer, and two (2) centrifuge tubes were returned as well.Neither tube returned contained labels, confirming the complaint.A retain analysis could not be conducted because retain samples of this product are not kept by bd.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 not received prior complaints 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 2 tubes in the bd d-cube¿ consumables kit did not have labels on them.There was no report of user or patient impact.The following information was provided by the initial reporter, translated from japanese: "this is a report about a labeling issue of the centrifuge tubes according to the customer¿s report, there were tubes without a label.".

Manufacturer Narrative

It has been determined that mfr.Report # 3008007472-2022-00001 and its follow up report #1 were sent in error.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.

• Brand Name: BD D-CUBE¿ 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 ; 8015296192
• MDR Report Key: 13425847
• MDR Text Key: 287681162
• Report Number: 3008007472-2022-00001
• 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,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 491460
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• 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