NEEDLE SPINAL S/SU 27GA 3-1/2IN WHITACRE

Description of Event or Problem

IT IS REPORTED CONNECTION ISSUE WITH NEEDLE AND SYRINGE. EVENT DETAILS: THE NEEDLE DOES NOT FIT PROPERLY WITH THE DIFFERENT SYRINGES THAT WERE TESTED, RESULTING IN LEAKAGE DURING THE ADMINISTRATION OF THE MEDICATION IN THIS CASE FOR ANESTHESIA. ADDITIONAL INFORMATION COULD YOU PLEASE CONFIRM IF THE DIFFERENT SYRINGES TESTED ARE FROM BD? YES. COULD YOU PLEASE PROVIDE THE SYRINGE CATALOG AND LOT NUMBER? 4134412. COULD YOU PLEASE CLARIFY THIS MATCHING PROBLEM USING THE SAME OR DIFFERENT PRODUCT CATALOGS? NO. IS THERE ANY IMPACT FOR THE PATIENT? YES. PROVIDE DETAILS OF THE IMPACT/HARM TO THE PATIENT? DETECTED PRIOR TO ADMINISTRATION WAS THERE EXPOSURE TO BLOOD OR CHEMOTHERAPY ON MUCOUS MEMBRANES OR SKIN (DETAIL)? NO.

Additional Manufacturer Narrative

INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

Additional Manufacturer Narrative

TWO PHOTOS AND ONE PHYSICAL SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLE WAS SUBMITTED FOR INSPECTION FOR VISUAL CHARACTERISTICS AND TESTING. THE INSPECTION WAS EXECUTED, AND THE SAMPLE COMPLIES WITH THE EXPECTED CHARACTERISTICS, THE REPORTED FAILURE OF CONNECTIVITY ISSUE WAS NOT OBSERVED IN THE SAMPLE AND COULD NOT BE VERIFIED. 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, A ROOT CAUSE COULD NOT BE DETERMINED AS THE INCIDENT COULD NOT BE VERIFIED. BD DEVICES ARE DESIGNED TO BE MOLDED COMPONENTS COMPATIBLE WITH ISO594 DIMENSIONS. THEREFORE, IT IS RECOMMENDED TO USE SYRINGES COMPATIBLE WITH ISO STANDARDS. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.