APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT

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.

Description of Event or Problem

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.