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

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 BATCH REPORTED: BATCH: 3100744. BATCH CREATION DATE: 2023-06-13. BATCH EXPIRATION DATE: 2028-09-30 H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

Description of Event or Problem

D SPINAL NEEDLE 27G(CAT NO.405081) LOT: 3100744 EXP.: 3/31/2028 - FOUND FLUID LEAKAGE BETWEEN JOINT BD SPINAL NEEDLE 27G (CAT NO. 405081) LOT 3286308 EXP.9/30/2028 - FOUND FLUID LEAKAGE BETWEEN JOINT. STOP USING THESE LOT NO. CHANGE LOT NO. TO CUSTOMER FOR TRIAL. ADDITIONAL INFORMATION: NO HARM TO PATIENT OR CAREGIVER. 3. THE REPORT INCIDENT NOTICED DURING USE. 4. CSF FLUID LEAK OUT DURING CHANGE SYRINGE.

Additional Manufacturer Narrative

SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE, A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE TEAMS INVESTIGATION, BD DEVICES ARE DESIGNED TO BE MOLDED COMPONENTS COMPATIBLE WITH ISO (INTERNATIONAL ORGANIZATION FOR STANDARDIZATION) DIMENSIONS. THEREFORE, IT IS RECOMMENDED TO USE SYRINGES COMPATIBLE WITH ISO STANDARDS. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.