NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE

Additional Manufacturer Narrative

INVESTIGATION RESULTS: TWO PHOTOS AND A VIDEO WERE PROVIDED FROM THE CUSTOMER AS EVIDENCE FOR THIS INVESTIGATION. THE PHOTOS SHOW THE SHELF CASE OF (B)(4).UNITS WITH THE SHELF LABEL FOR CATALOG 405180 BATCH NUMBER 4151209. THE VIDEO SHOWS THE CUSTOMER HOLDING THE SYRINGE WITH THE NEEDLE ATTACHED. IT CAN BE SEEN IN THE VIDEO THAT THE CUSTOMER HAD TROUBLE COMPRESSING THE SYRINGE. WITHOUT A PHYSICAL SAMPLE, IT CANNOT BE DETERMINED IF THE ISSUE IS WITH THE NEEDLE; THEREFORE, THE REPORTED INCIDENT OF THE NEEDLE BEING BLOCKED CANNOT BE VERIFIED. IF A PHYSICAL SAMPLE BECOMES AVAILABLE, THE COMPLAINT WILL BE RE-OPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

INVESTIGATION RESULTS: TWO PHOTOS, A VIDEO, AND FIVE PHYSICAL SAMPLES WERE PROVIDED FROM THE CUSTOMER AS EVIDENCE FOR THIS INVESTIGATION. THE PHOTOS SHOW THE SHELF CASE OF (B)(4) UNITS WITH THE SHELF LABEL FOR CATALOG 405180 BATCH NUMBER 4151209. THE VIDEO SHOWS THE CUSTOMER HOLDING THE SYRINGE WITH THE NEEDLE ATTACHED. IT CAN BE SEEN IN THE VIDEO THAT THE CUSTOMER HAD TROUBLE COMPRESSING THE SYRINGE. HOWEVER, THE NEEDLES WERE SENT FOR TESTING AND NO ISSUES WERE FOUND. THE NEEDLES PASSED VISUAL INSPECTION AND FIT TESTING. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

Description of Event or Problem

MATERIALS: 405180 BATCH#: 4151209. ADDITIONAL INFORMATION: 1. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN. WITH SEVERAL DOCTORS AND MORE SPECIFICALLY WITH A RADIOLOGIST WHO INFORMED US AND KEPT THE DEFECTIVE NEEDLES. 3. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? THE RADIOLOGIST HAS TO START THE PROCEDURE AGAIN BY REPOSITIONING HIS NEEDLE IN THE INTENDED PLACE, MORE RISK OF INFECTION AND A LOT OF INCONVENIENCE FOR THE PATIENT, THE RADIOLOGIST USED SO MUCH FORCE THAT A MARK REMAINED ON HIS HAND AND WITHOUT SUCCESS!