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	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
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 the bd affirm atts, an employee at a doctor office failed to properly break the ampule and transfer the patient sample.The entire ampule was incorrectly transferred into the transportation tube, so when processing, operator was pricked by ampule glass.The patient was positive for unknown organism.Supervisor sent injured operator to be seen by a medical professional in their facility right away.
Event or Problem Description
It was reported that upon use of the bd affirm atts, an employee at a doctor office failed to properly break the ampule and transfer the patient sample.The entire ampule was incorrectly transferred into the transportation tube, so when processing, operator was pricked by ampule glass.The patient was positive for unknown organism.Supervisor sent injured operator to be seen by a medical professional in their facility right away.
Additional Manufacturer Narrative
Investigation summary: bd initiated investigation on the customer report regarding patient injury while using the affirm atts (catalog # 446255) due to glass shards.Bd implemented the packaging of the atts ampule crushing tool to prevent occurrence of user injury caused by the ampoule.All current atts kits contain 1 tool provided in each kit, and additional tools are available from bd technical services.Bd strongly recommends the use of this tool, and to follow package insert instructions explicitly for the proper use of this tool to eliminate chances of injury due to glass shards.

• 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: 22569425
• Report Number: 1119779-2025-01779
• Device Sequence Number: 13073393
• Product Code: LIO
• UDI-Device Identifier: 30382904462551
• UDI-Public: (01)30382904462551(17)260131(10)B01H036M
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/17/2026

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: B01H036M
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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