MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) KIT BD MAX CTGCTV2 US; TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM

Catalog Number	443904
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using the kit bd max ctgctv2 us the user noted a mix of product within the kit, eleven (11) master mixes were labeled with b7 instead of d3.The barcodes labels on the master mix would not scan when loaded on the instrument.No health impact or consequence reported.
Additional Manufacturer Narrative
There were multiple medical device types reported to be involved.The information for the additional device type is as follows: d2b: medical device type: lsl, mkz, ouy e1: initial reporter phone #: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following information has been updated with corrected and/or additional information: d.9.Device available for eval? yes.D.9.Returned to manufacturer on: 2024-03-22.Investigation summary: the complaint investigation for incorrect snap in tubes (master mix) in the bd max¿ ctgctv2 kit (ref (b)(4)) lot 3353052 was performed by the review of manufacturing records, visual inspection of photos provided by the customer, visual evaluation of returned material, and verification of complaints history.Customer complained about eleven incorrect master mix tubes in one bd max¿ ctgctv2 kit that were not having the correct tube id.The manufacturing investigation revealed that during bagging process of master mix tubes lot 3355652, some tubes were found with a b7 foil instead of the expected d3 foil identification.The manufacturing investigation determined that the master mix found with incorrect foil id was the correct one but a foil supplier issue was the cause of the incorrect tube id on the foil.A small portion of the tube foil used during production had the incorrect tube id (one foil sheet with incorrect 2d barcode in the foil package representing a maximum of 0.4% of the tubes further processed).Manufacturing controls in place allowed detection and rejection of the majority of those tubes (about 88%).However, some tubes potentially sealed with incorrect 2d barcode were not found and the investigation concluded that the remaining tubes were either rejected during the manufacturing process or already packaged.Since it was not possible to inspect the packaged material, and because incorrect foil id would cause an instrument error (catalog fail) on the bd max¿ instrument preventing the use of these tubes and not presenting any risk of erroneous result, the lot was accepted and released.Actions were taken to improve detection of foil with incorrect id.Inspection of returned materials provided confirms the customer issue.There is no indication of incorrect master mix tubes in bags based on the analysis of the complaints received on bd max¿ ctgctv2 kit lot 3353052.Based on the investigation, the root cause was identified as a foil supplier issue.Bd confirms the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action since no new hazard was identified and actions identified during production issue were already completed.Bd apologizes for the inconvenience that this may have caused.Bd quality will continue to monitor for trends.H3 other text : see h.10.
Event or Problem Description
It was reported while using the kit bd max ctgctv2 us the user noted a mix of product within the kit, eleven (11) master mixes were labeled with b7 instead of d3.The barcodes labels on the master mix would not scan when loaded on the instrument.No health impact or consequence reported.

• Brand Name: KIT BD MAX CTGCTV2 US
• Common Device Name: TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
• Manufacturer (Section D): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer (Section G): GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS); 2555 blv. du parc techn; quebec
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18913981
• Report Number: 3007420875-2024-00023
• Device Sequence Number: 20555993
• Product Code: LSL
• UDI-Device Identifier: 00382904439040
• UDI-Public: (01)00382904439040
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K182692
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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 Expiration Date: 06/28/2025
• Device Catalogue Number: 443904
• Device Lot Number: 3353052
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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