NEEDLE SPINAL S/SU 20GA 3-1/2IN QUINCKE

Additional Manufacturer Narrative

CORRECTION: ADDED LEAK A CODE. INVESTIGATION RESULTS: A VIDEO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. NO ACTUAL SAMPLES WERE RECEIVED FOR THIS INVESTIGATION. IN THE VIDEO IS SEEN A HEALTHCARE PROVIDER INSERTING THE NEEDLE (NO INTRODUCER IS BEING USED) IN THE PATIENT¿S BACK, IT IS OBSERVED THAT THE HEALTHCARE PROVIDER ADMINISTERS MEDICATION AND DROPS OF MEDICATION RUN THROUGH THE GLOVES OF THE HEALTHCARE PROVIDER. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE POTENTIAL ROOT CAUSE IS ATTRIBUTED TO HANDLING-RELATED ISSUES, AS THE COMPLAINT VERBATIM STATES, ¿THE NEEDLE DOES NOT FIT CORRECTLY,¿ AND VIDEO EVIDENCE SHOWS THE HEALTHCARE PROVIDER HOLDING THE DEVICE AT THE CONNECTION DURING USE. SINCE BD DEVICES ARE MOLDED TO ISO 594-DIMENSIONAL SPECIFICATIONS, THE USE OF SYRINGES COMPLIANT WITH ISO STANDARDS IS RECOMMENDED TO REDUCE THE RISK OF THE REPORTED FAILURE MODE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE, IT IS EVIDENT THAT THE NEEDLE DOES NOT FIT CORRECTLY WITH THE SYRINGE, CAUSING MEDICATION LEAKS, LOSS OF CONTENT, AND THE INABILITY TO USE THE DEVICE SAFELY.