UNKNOWN SPINAL NEEDLE

Additional Manufacturer Narrative

INITIAL MDR, IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

EVENT DETAILS: IMPROPER COUPLING OF THE NEEDLE WITH THE 3ML SYRINGE, CAUSING LEAKAGE DURING ANESTHESIA, RESULTING IN AN INADEQUATE DOSE THAT IMPAIRED THE BLOCK. THIS EPISODE OCCURRED MORE THAN ONCE WITH DIFFERENT PATIENTS, USING DIFFERENT SYRINGES AND DIFFERENT ANESTHESIOLOGISTS AT DIFFERENT TIMES.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

AS NO PHYSICAL SAMPLE, VALID PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.