SAFETY SUBCULTURE UNIT
Report
- Report Number
- 3003895930-2025-00001
- Event Type
- Malfunction
- Date Received
- December 30, 2025
- Date of Event
- November 30, 2025
- Report Date
- January 29, 2026
- Manufacturer
- ITL ASIA PACIFIC SDN BHD.
- Product Code
- LIB
- UDI-DI
- 19555249491110
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
ITL HAS CONCLUDED BASED ON ITS INVESTIGATION THAT THE COMPLAINT LOT WAS MANUFACTURED IN ACCORDANCE WITH THE ESTABLISHED PROCEDURES. NO MANUFACTURING NONCONFORMANCE WAS IDENTIFIED, AND NO TREND OF LEAKAGE OR RELATED DEFECTS WAS OBSERVED. THE A100720 UNIT IS SOLD AS A STANDALONE DEVICE; THEREFORE, THE REPORTED LEAKAGE IS LIKELY ATTRIBUTABLE TO THE CULTURE BOTTLE SEPTUM NOT ACHIEVING A COMPLETE SEAL FOLLOWING REMOVAL OF THE A100720 UNIT. NO FURTHER INPUT WAS RECEIVED FROM THE CUSTOMER, NO TRENDS HAVE BEEN OBSERVED IN THE POST MARKET DATA. POTENTIAL USER ERROR CANNOT BE RULED OUT.
THE PRELIMINARY INVESTIGATION INCLUDED:(1) ANALYSIS OF COMPLAINT HISTORY AND GLOBAL TREND DATA AND (2) VERIFICATION OF INSTRUCTIONS FOR USE (IFU) COMPLIANCE. PRELIMINARY RESULTS AND CONCLUSIONS ON, DEVICE PERFORMANCE: (1) DEVICE IS NOT AVAILABLE TO BE RETURNED TO ITL FOR PHYSICAL INSPECTION AND FUNCTIONAL TESTING. (2) 0 SIMILAR EVENT FROM 7.6 MILLION UNITS SOLD WORLDWIDE SINCE 2009. INSTRUCTIONS FOR USE (IFU) AND USER COMPLIANCE: THE IFU CLEARLY STATES UNDER WARNINGS AND PRECAUTIONS: "WEAR PROPER PERSONAL PROTECTIVE EQUIPMENT AND VENT CULTURE BOTTLES UNDER A SAFETY HOOD OR AS YOUR FACILITY PROCEDURE REQUIRES." THE IFU ALSO PROVIDES DETAILED STEPS FOR SAFE HANDLING AND REMOVAL TO AVOID SPLATTER. THE PROCEDURE WAS CONDUCTED INSIDE A BIOSAFETY CABINET, WHICH IS APPROPRIATE AND CONSISTENT WITH IFU RECOMMENDATIONS. HOWEVER, THE INVESTIGATION ALSO CONFIRMED THAT THE STAFF MEMBER DID NOT WEAR GLOVES DURING THE PROCEDURE, CONTRARY TO IFU INSTRUCTIONS. THIS NON-COMPLIANCE SIGNIFICANTLY INCREASED THE RISK OF EXPOSURE. INVESTIGATION IS STILL ONGOING.
DURING A SUBCULTURE PROCEDURE AT LEICESTER ROYAL INFIRMARY (UK), IT WAS REPORTED THAT THE SAFETY SUBCULTURE UNIT (SCU) A100720 CREATED A LARGE HOLE IN THE SEPTUM OF THE BIOMÉRIEUX BLOOD CULTURE BOTTLE. THIS DEFECT LED TO LEAKAGE OF BLOOD FROM THE SEPTUM WHILE THE UNIT WAS IN PLACE (WHEN INVERTED) AND AFTER REMOVAL. AS A RESULT, A POSITIVE BLOOD CULTURE (ALLEGEDLY BRUCELLA SPECIES, HAZARD GROUP 3) LEAKED, EXPOSING THE STAFF MEMBER'S BARE HAND BECAUSE THE REQUIRED PPE WAS NOT WORN. THE EXPOSURE REQUIRED ADMINISTRATION OF ANTIBIOTIC PROPHYLAXIS; HOWEVER, NO CLINICAL SIGNS OR SYMPTOMS WERE REPORTED, AND THERE WAS NO HOSPITALIZATION OR PERMANENT HARM. THE PROCEDURE WAS PERFORMED INSIDE A BIOSAFETY CABINET.
DURING A SUBCULTURE PROCEDURE AT LEICESTER ROYAL INFIRMARY (UK), IT WAS REPORTED THAT THE SAFETY SUBCULTURE UNIT (SCU) A100720 CREATED A LARGE HOLE IN THE SEPTUM OF THE BIOMÉRIEUX BLOOD CULTURE BOTTLE. THIS DEFECT LED TO LEAKAGE OF BLOOD FROM THE SEPTUM WHILE THE UNIT WAS IN PLACE (WHEN INVERTED) AND AFTER REMOVAL. AS A RESULT, A POSITIVE BLOOD CULTURE (ALLEGEDLY BRUCELLA SPECIES, HAZARD GROUP 3) LEAKED, EXPOSING THE STAFF MEMBER'S BARE HAND BECAUSE THE REQUIRED PPE WAS NOT WORN. THE EXPOSURE REQUIRED ADMINISTRATION OF ANTIBIOTIC PROPHYLAXIS; HOWEVER, NO CLINICAL SIGNS OR SYMPTOMS WERE REPORTED, AND THERE WAS NO HOSPITALIZATION OR PERMANENT HARM. THE PROCEDURE WAS PERFORMED INSIDE A BIOSAFETY CABINET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1768764 | SAFETY SUBCULTURE UNIT | SCU | LIB | ITL ASIA PACIFIC SDN BHD. | 24F012 | 19555249491110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |