29 GA X 8MM PEN NEEDLE BD MEDICAL - INFUSION THERAPY SYSTEMS Report # 1578893
NO PRODUCT RETURN IS ANTICIPATED AS COMPLAINT INDICATES THAT THE PRODUCT HAS BEEN DISCARDED. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED. NO OBVIOUS TRENDS WERE NOTED. DEVICE HISTORY REVIEW WAS CONDUCTED AND NO ANOMALIES NOTED. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.
29 GA X 8MM PEN NEEDLE BD MEDICAL - INFUSION THERAPY SYSTEMS Report # 1578893
MEDICAL PROFESSIONAL REPORTED NURSE WENT TO ADMINISTER INSULIN IN THE PT'S ABDOMEN AND WHEN SHE REMOVED THE NEEDLE FROM THE PT AND WENT TO TAKE THE NEEDLE OFF THE PEN, SHE OBTAINED A NEEDLE STICK. CUSTOMER STATES THE SHIELD WHICH COVERS THE NEEDLE DID NOT ENGAGE AND NEEDLE WAS EXPOSED.