MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM; MULTIPLE VAGINITIS/VAGINOSIS-ASSOCIATED PATHOGEN NUCLEIC ACID IVD KIT

Catalog Number	446255
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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 upon use of bd affirm¿ atts, during swabbing for specimen collection, the swab tip became separated from the shaft.There was no report of patient impact.
Additional Manufacturer Narrative
Investigation summary: bd initiated an investigation into the customer¿s report of the swab head detaching from the shaft during specimen collection using the affirm vpiii ambient temperature transport system (atts) collection kit.Information provided by the customer indicated that the patient was self-collecting the swab when the event occurred.No patient harm resulted.As per the product labeling, vaginal swabs collected using the affirm atts kit should be collected by a clinician, and there are no instructions or product claims for patient self-collection.Patients are to be placed in position for a pelvic examination and a speculum inserted to allow proper specimen collection.Bd recommends following the package insert instructions for collection of vaginal specimens using the affirm vpiii atts kit.
Event or Problem Description
It was reported that upon use of bd affirm¿ atts, during swabbing for specimen collection, the swab tip became separated from the shaft.There was no report of patient impact.

• Brand Name: BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM
• Common Device Name: MULTIPLE VAGINITIS/VAGINOSIS-ASSOCIATED PATHOGEN NUCLEIC ACID IVD KIT
• 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: 24282868
• Report Number: 1119779-2026-00106
• Device Sequence Number: 9927357
• Product Code: LIO
• UDI-Device Identifier: 30382904462551
• UDI-Public: (01)30382904462551(17)260131(10)B03H100M
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K920536
• 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): 04/03/2026

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: 01/31/2026
• Device Catalogue Number: 446255
• Device Lot Number: B03H100M
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2025
• 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