MAUDE Adverse Event Report: BECTON DICKINSON & CO. (SPARKS) BD ONCLARITY¿ HPV SUREPATH¿ DILUENT TUBES; KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Catalog Number	445329
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd onclarity¿ hpv surepath¿ diluent tubes, the tubes were found to have an incorrect label marking in nine (9) boxes.There was no report of patient impact.
Additional Manufacturer Narrative
H.6.Investigation summary: bd integrated diagnostic systems initiated an investigation into the barcode labels on the hpv lbc diluent us surepath tubes (catalog # 445329, batch # 3087411).These tubes were manufactured prior to the implementation of the new labeling scheme.These tubes were properly labeled with the "^" prefix.The manufacturing of tubes with the label containing the "m" prefix did not occur until november, 2023.As stated in the customer in-take description, the tubes were orderd in september, 2023.Although the customer photographic evidence displayed the "^" prefix, this complaint is unconfirmed as the labeling change noted by the customer was in accordance with specifications.
Event or Problem Description
It was reported when using the bd onclarity¿ hpv surepath¿ diluent tubes, the tubes were found to have an incorrect label marking in nine (9) boxes.There was no report of patient impact.

• Brand Name: BD ONCLARITY¿ HPV SUREPATH¿ DILUENT TUBES
• Common Device Name: KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
• Manufacturer (Section D): BECTON DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18621749
• Report Number: 1119779-2024-00057
• Device Sequence Number: 16745578
• Product Code: MAQ
• UDI-Device Identifier: 30382904453290
• UDI-Public: (01)30382904453290
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P160037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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: 01/31/2025
• Device Catalogue Number: 445329
• Device Lot Number: 3087411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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