SEE H.11

Additional Manufacturer Narrative

D1: MEDICAL DEVICE BRAND NAME: BD CALIBRATED DISPOSABLE INOCULATING LOOPS, GREEN 1L (20X50 LOOPS). D2A: COMMON DEVICE NAME: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED AND PROMOTED FOR A SPECIFIC MEDICAL USE. INVESTIGATION SUMMARY: COMPLAINT HISTORY REVIEW: A REVIEW OF PAST COMPLAINTS ON THIS PRODUCT OVER THE PAST 12 MONTHS DOES NOT INDICATE A TREND ON THIS ISSUE. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD DOES NOT INDICATE ANY MANUFACTURING ISSUES. SAMPLE ANALYSIS: A REVIEW OF THE PHOTOS DID SHOW BLACK MATTER ON THE PLASTIC LOOP SHAFTS. NO RETURNS WERE AVAILABLE. THE RETENTION SAMPLES DID NOT EXHIBIT ANY DEFECTS. EVALUATIONS RESULTS: BASED ON THE INVESTIGATION, THE COMPLAINT WAS CONFIRMED ON PHOTOS. THERE IS NO SYSTEMIC FAILURE IN THE MANUFACTURING PROCESS AND THE RETENTION SAMPLES WERE SATISFACTORY. THERE IS NO COMPLAINT TREND ON THIS ISSUE. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION OF THE INVESTIGATION, THE COMPLAINT WAS CONFIRMED. NO FURTHER ACTIONS WILL BE TAKEN AS NO CONFIRMED TREND HAS BEEN IDENTIFIED. THIS IS AN ISOLATED INCIDENT. BD WILL CONTINUE TO MONITOR FOR TRENDING. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

Description of Event or Problem

IT WAS REPORTED WHILE USING BD CALIBRATED DISPOSABLE INOCULATING LOOPS, GREEN 1L (20X50 LOOPS), THERE WAS MOLD CONTAMINATION WHICH LED TO FALSE RESULTS. THERE WAS NO REPORT OF PATIENT IMPACT.