MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) ONCLARITY; HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD

Catalog Number	444075
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that during use of bd onclarity¿ hpv assay reagent pack for bd cor, an hpv p3 false positive patient result was obtained.Test was repeated on new sample and was p3 negative.There was no report of patient impact.
Event or Problem Description
It was reported that during use of bd onclarity¿ hpv assay reagent pack for bd cor, an hpv p3 false positive patient result was obtained.Test was repeated on new sample and was p3 negative.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: the complaint investigation for discrepant result when using the bd onclarity¿ hpv assay for bd cor¿ system kit (ref.444075) from lot 5217918 was performed by the review of manufacturing records and by the complaint¿s history review.The review of quality control records of bd onclarity¿ hpv assay for bd cor¿ system kit lot 5217918 revealed no anomalies that could explain the customer¿s discrepant result.According to the information received, the initial test was performed with a self collected sample, gave a p3 positive result, and a retest was performed using a new sample from a lbc collection device (clinician collected).The new sample came out negative.Discussion with the customer about the correct procedure to recollect a sample was performed and since then no other issue was reported.Despite multiple attempts made to receive information, data was no longer available for the investigation.Based on the available information, and without data, bd is unable to identify a cause for the customer issue.There is no indication of a reagent issue based on the analysis of the complaints received for discrepant result on bd onclarity¿ hpv assay for bd cor¿ system kit lot 5217918.The root cause was not identified.Bd cannot confirm the complaint based on the investigation that was performed.Bd did not initiate a corrective and preventive action since no new hazard was identified.

• Brand Name: ONCLARITY
• Common Device Name: HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD
• 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: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 23575122
• Report Number: 1119779-2025-05442
• Device Sequence Number: 18710287
• Product Code: MAQ
• UDI-Device Identifier: 00382904440756
• UDI-Public: (01)00382904440756(17)260912(10)5251721
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 06/24/2026

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: 09/12/2026
• Device Catalogue Number: 444075
• Device Lot Number: 5251721
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 04/14/2026; 06/24/2026
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 04/24/2026; 06/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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