MAUDE Adverse Event Report: HOLOGIC, INC. APTIMA MULTITEST SPECIMEN COLLECTION KIT; DEVICE, SPECIMEN COLLECTION

Catalog Number	ASY-08848
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic reached out to the customer multiple times and attempted to obtain more information on the swab lot, collection method, and sample type but did not receive a response.Hologic evaluated retention materials from this lot ln 922935 but was not able to replicate the customer issue.Hologic has not been informed of any adverse outcomes related to this issue.
Event or Problem Description
On (b)(6) 2025, customer reported to hologic that in two separate patient encounters, the swab tip from the aptima multitest swab specimen collection kit (ln 922935) detached from the stick and remained inside the patient.Customer reported that the two patient encounters occurred within 24 hours prior to their report to hologic.In both instances, the physician was able to remove the swab tip without any reported patient harm.Customer did not provide patient information or confirmation of swab specimen type or collection method.This report is to document the first affected patient encounter.Hologic has not learned of any adverse outcomes related to this event.

• Brand Name: APTIMA MULTITEST SPECIMEN COLLECTION KIT
• Common Device Name: DEVICE, SPECIMEN COLLECTION
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• Manufacturer Contact: grace nareau ; 10210 genetic center drive; san diego, CA 92121 ; 8584108040
• MDR Report Key: 23407944
• Report Number: 2024800-2025-00068
• Device Sequence Number: 15635240
• Product Code: LIO
• UDI-Device Identifier: 25420045510187
• UDI-Public: 25420045510187
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K032554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: ASY-08848
• Device Lot Number: 922935
• 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: 10/13/2025
• Initial Report FDA Received Date: 10/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown