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

Catalog Number	301041-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hologic completed a retention check using the retained lot number 880984v of aptima multitest swab specimen collection kit.Pressure was applied to the tip in various directions to simulate potential stress placed on the swab during sample collection.The tip was able to withstand a considerable amount of force and bend in various directions before any plastic deformation/fray was observed.A previous event search for aptima multitest swab specimen collection kit lot number 880984v and swab lot numbers ln: 882799 and ln: 884783 showed that as of 07/25/2024, there were no similar complaints associated with this lot.A device history record review was performed, confirming that the device was released according to specifications.Hologic completed a risk assessment.The patient was impacted as the collection kit swab broke and became lodged in their cervix which required removal by the physician.However, there was no harm or subsequent injury reported.Investigation into this issue is currently in process with the swab manufacturer.
Event or Problem Description
On 07/23/24, a customer contacted hologic to report a broken swab tip that occurred during specimen collection on 07/19/24 using the aptima unisex swab specimen collection kit, lot number 880984v.According to the customer, approximately 1 cm of the swab tip broke inside the cervix.The tip of the swab was safely removed by the physician with tweezers and no injuries were reported.No additional treatment was needed.Hologic is reporting this incident because a medical intervention was required to prevent temporary or permanent impairment or injury.

• Brand Name: APTIMA MULTITEST SWAB 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: maria osorio ; 10210 genetic center drive; san diego, CA 92121 ; 8584108109
• MDR Report Key: 19951866
• Report Number: 2024800-2024-00011
• Device Sequence Number: 13002387
• Product Code: LIO
• UDI-Device Identifier: 25420045506272
• UDI-Public: 25420045506272
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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): 08/09/2024

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: 301041-01
• Device Lot Number: 880984V
• 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: 07/23/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention
• Patient Sex: Unknown