MAUDE Adverse Event Report: GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) BD MAX CT/GC/TV; TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM

Model Number	442970
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using a mix of products in the pack was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "in the kit, instead of having 2 x extraction tubes (b2), they only have one bag.The second one being extraction tubes for enteric viral panel (d4).".
Additional Manufacturer Narrative
H6: investigation summary: the complaint investigation for mix of extraction tubes pouches between two consecutive kit lots in the kit bd max ctgctv (ref #(b)(4)) from lot 1039524 was performed by the review of manufacturing records, retention material inspection and verification of complaints history.Customer reported that a bd max¿ ctgctv kit from lot 1039524 contained one bd max¿ ctgctv extraction tubes (tx) pouch and one bd max¿ enteric viral panel extraction tubes pouch, instead of two bd max¿ ctgctv extraction tubes pouches.Review of the manufacturing process revealed that the bd max¿ ctgctv kit lot 1039524 was produced using the fully automated process.The lot produced just prior corresponded to a bd max¿ enteric viral panel kit.Discussions with the manufacturing team revealed that, since some conveyors are partially covered by a stainless steel plate, it is possible for a pouch gets stuck between the conveyor belt and the stainless steel wall adjacent to the conveyor and not noticed during line clearance.If that occurs and reconciliation process is within its tolerance, it would be possible that the pouch is released during the subsequent production batch.The retain material of bd max ct/gc/tv from lot 1039524 was inspected and no anomaly was observed.There is no indication of an increase in complaints for mix of tubes pouches between two consecutive kit lots of bd max products.The root cause was not identified but a manufacturing issue is suspected.Bd confirms the complaint based on the investigation that was performed.No corrective and preventive action (capa) was initiated at this time since a modification of the manufacturing equipment was done to allow full visibility of the conveyors (stainless steel plates replaced by plexiglass plates) in order to improve the manufacturing line clearance process.H3 other text : see h10.
Event or Problem Description
It was reported that while using a mix of products in the pack was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "in the kit, instead of having 2 x extraction tubes (b2), they only have one bag.The second one being extraction tubes for enteric viral panel (d4).".

• Brand Name: BD MAX CT/GC/TV
• 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
• MDR Report Key: 11912741
• Report Number: 3007420875-2021-00015
• Device Sequence Number: 4417514
• Product Code: OUY
• UDI-Device Identifier: 00382904429706
• UDI-Public: 00382904429706
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K151589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 01/11/2022
• Device Model Number: 442970
• Device Catalogue Number: 442970
• Device Lot Number: 1039524
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1