APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT
Report
- Report Number
- 2024800-2023-00015
- Event Type
- Injury
- Date Received
- August 31, 2023
- Date of Event
- August 9, 2023
- Report Date
- July 19, 2024
- Manufacturer
- HOLOGIC, INC.
- Product Code
- LIO
- UDI-DI
- 25420045510187
- PMA / PMN Number
- K032554
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
HOLOGIC COMPLETED A RETENTION CHECK USING FOUR RETAINED LOTS OF APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT, AND THE REPORTED MALFUNCTION COULD NOT BE REPRODUCED USING RETAINED MATERIAL. THE SWAB SOFT TIPS REMAINED INTACT AFTER SIMULATING SELF-COLLECTION. A PREVIOUS EVENT SEARCH FOR APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT LOT 331515V SHOWED THAT AS OF (B)(6) 2023, 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 THEY REQUIRED AN INVASIVE PROCEDURE TO REMOVE THE SWAB SOFT TIP FROM THE VAGINAL CAVITY ON TWO OCCASIONS. HOWEVER, THERE WAS NO HARM OR SUBSEQUENT INJURY REPORTED. INVESTIGATION INTO THIS ISSUE IS CURRENTLY IN PROCESS WITH THE SWAB MANUFACTURER.
THE FOLLOWING IS A RESUBMISSION THAT WAS INITIALLY SUBMITTED AS A FOLLOW UP MDR (2024800-2023-00015) ON 10/12/2023 BY HOLOGIC. HOLOGIC¿S SWAB SUPPLIER, PURITAN, COMPLETED AN INVESTIGATION. PURITAN REVIEWED THE BATCH RECORDS OF FOUR IMPACTED SWAB LOT NUMBERS, INCLUDING THE AFFECTED LOT 331515V. NO ISSUES WERE FOUND FROM THE BATCH RECORDS, AND ALL RUNS WERE WITHIN THE VALIDATED PARAMETERS. PURITAN NOTED THAT DURING PRODUCTION, OPERATORS CHECK 10 SWABS EVERY 30 MINUTES FOR TIP ADHESION. PURITAN ALSO CHECKED THE TIPS OF THE RETAINS OF THE LOTS IMPACTED AND FOUND NO ISSUES WITH TIP ADHESION. (B)(4). BASED ON SUPPLIER¿S INVESTIGATION, THE EVENT IS CONSIDERED A USER ERROR AND NOT A SYSTEMIC ISSUE WITH THE SWAB. REVIEW OF THE RISK FILE DID NOT IDENTIFY ANY NEW RISK TO PATIENT SAFETY. EVENT SEVERITY AND THE OCCURRENCE RATE WERE STILL IN LINE WITH THE RISK DOCUMENTED IN THE RISK MANAGEMENT FILE. NO INJURIES WERE REPORTED TO HOLOGIC FROM THIS INCIDENT. HOLOGIC IS REPORTING THIS INCIDENT BECAUSE A MEDICAL INTERVENTION WAS REQUIRED TO PREVENT TEMPORARY OR PERMANENT IMPAIRMENT OR INJURY.
SECTION B5: STATED, "FOLLOW-UP REPORT. SEE SECTION H10". WHEN IT SHOULD HAVE REFERENCED SECTION H11.
ON (B)(6) 2023, A HOLOGIC MOLECULAR APPLICATIONS SPECIALIST (MAS) REPORTED ON BEHALF OF A CUSTOMER THAT THE SWAB SOFT TIP OF THE APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT DETACHED FROM THE SWAB SHAFT AND GOT STUCK INSIDE THE VAGINAL CAVITY OF A FEMALE PATIENT DURING SELF-COLLECTION. THE PATIENT WAS USING A SWAB FROM THE APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT, LOT NUMBER 331515V. AFTER THIS INCIDENT, A PHYSICIAN REMOVED THE SWAB SOFT TIP FROM THE PATIENT. THEN, THE PATIENT RECEIVED ANOTHER APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT FOR SELF-COLLECTION OF A VAGINAL SPECIMEN, BUT THE SWAB SOFT TIP DETACHED AGAIN AND WAS LEFT IN THE PATIENT¿S VAGINAL CAVITY. THE PATIENT ONCE AGAIN HAD TO CONSULT A PHYSICIAN TO HAVE THE SWAB SOFT TIP REMOVED. PER CUSTOMER FEEDBACK, THE CUSTOMER IS UNSURE IF THE PATIENT WAS ADEQUATELY INFORMED OF THE DEVICE'S INSTRUCTIONS FOR USE PRIOR TO THE PATIENT USING APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT. THE CUSTOMER INDICATED THAT THE PATIENT DID NOT NOTICE ANY DAMAGE TO DEVICE PRIOR TO USAGE. NO INJURIES WERE REPORTED TO HOLOGIC FROM THIS INCIDENT. HOLOGIC IS REPORTING THIS INCIDENT BECAUSE A MEDICAL INTERVENTION WAS REQUIRED TO PREVENT TEMPORARY OR PERMANENT IMPAIRMENT OR INJURY.
FOLLOW-UP REPORT. SEE SECTION H10.
FOLLOW-UP REPORT. SEE SECTION H10.
SEE SECTION H11:.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1183676 | APTIMA MULTITEST SWAB SPECIMEN COLLECTION KIT | DEVICE, SPECIMEN COLLECTION | LIO | HOLOGIC, INC. | 331515V | 25420045510187 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |