BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP JAPAN
Report
- Report Number
- 3006948883-2025-00712
- Event Type
- Malfunction
- Date Received
- September 25, 2025
- Date of Event
- August 29, 2025
- Report Date
- November 26, 2025
- Manufacturer
- BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
- Product Code
- GTY
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. LOT NUMBER WAS NOT REPORTED; HOWEVER, POTENTIAL LOT NUMBERS WERE PROVIDED. THE INFORMATION FOR THESE LOT NUMBERS ARE AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4220774 D4. MEDICAL DEVICE EXPIRATION DATE: 12-APR-2026 H4. DEVICE MANUFACTURE DATE: 07-AUG-2024 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT #: 4220796 D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2026 H4. DEVICE MANUFACTURE DATE: 07-AUG-2024 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 19-SEP-2025. H3: DEVICE EVAL BY MANUFACTURER?: YES. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES SAFETY (BROKEN SWAB) WHEN USING KIT VERITOR SYSTEM STREP A 10 TESTS JP (MATERIAL#: 256057), BATCH NUMBER UNKNOWN. THE CUSTOMER REPORTED THAT WHEN THE DOCTOR INSERTED THE COLLECTION SWAB INTO THE PATIENT'S MOUTH, THE COTTON TIP CAME OFF AND HAD TO BE REMOVED. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE COMPONENT SWAB BATCH NUMBER PROVIDED. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. THERE WERE RETURN PHOTOS AND SAMPLES RECEIVED. FROM THE PHOTOS PROVIDED, THE SWAB TIP WAS DETACHED. VISUAL INSPECTION WAS PERFORMED ON THE RETURN SAMPLES, AND IT WAS CONFIRMED THAT THE SWAB TIPS ARE SEPARATED FROM THE SHAFT. A TREND ANALYSIS FOR BROKEN SWAB WAS CONDUCTED, AND A TREND WAS IDENTIFIED. A SUPPLIER CORRECTIVE ACTION WAS OPENED WITH THE SUPPLIER, AND THE REPORTED ISSUE IS CONFIRMED. THE SUPPLIER WAS UNABLE TO DETERMINE THE ROOT CAUSE FOR THE ISSUE; HOWEVER, THEY HAVE IMPLEMENTED PROCESSES TO REDUCE THE RISK OF TIP DETACHMENT.
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP JAPAN, THE COTTON SWAB FROM THE TIP OF ONE (1) APPLICATOR FELL OFF INTO A PATIENT'S MOUTH DURING SAMPLE COLLECTION. THE PIECE OF COTTON WAS QUICKLY REMOVED AND NO ADVERSE IMPACT WAS REPORTED.
IT WAS REPORTED WHILE USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP JAPAN, THE COTTON SWAB FROM THE TIP OF ONE (1) APPLICATOR FELL OFF INTO A PATIENT'S MOUTH DURING SAMPLE COLLECTION. THE PIECE OF COTTON WAS QUICKLY REMOVED AND NO ADVERSE IMPACT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1849620 | BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP JAPAN | ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. | GTY | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |