TRULICITY PEN

Description of Event or Problem

PATIENT REPORTS THAT ON THE MORNING OF (B)(6) 2021, HE REMOVED THE RUBBER STOPPER ATTACHED TO THE END OF THE TRULICITY PEN, SWAB HIS SKIN AND PUT THE LARGER TUBE WITH THE NEEDLE ATTACHED ONTO HIS SKIN TO ADMINISTER THE MEDICATION. PATIENT STATES HE PRESSED THE BUTTON TO DISPENSE MEDICATION BUT DID NOT FEEL THE SENSATION OF THE NEEDLE PUNCTURE HIS SKIN AND DID NOT SEE A HOLE OR BLOOD AT THE SITE. PATIENT REPORTS THAT HE EXAMINED THE DEVICE AND NOTED THAT THE NEEDLE INJECTED INTO THE 1 INCH BASE THAT HAD NOT COME OUT WHEN HE INITIALLY REMOVED THE STOPPER. PATIENT NOTES NO HARM BUT STATES CONCERN WITH MISSED MEDICATION DOSE. PATIENT REPORTS CONTACTING THE MANUFACTURER WHO ALLEGED HE WAIT ABOUT 3 DAYS BEFORE APPLYING ANOTHER DOSE TO SEE IF THE MEDICATION HAD DISPENSED AND TO SEND THE DEVICE FOR INVESTIGATION. PATIENT STATED THAT DUE TO THE LACK OF EVIDENCE OF PUNCTURE AND SEEING LIQUID STILL IN THE VIAL, THAT HE USED ANOTHER PEN TO DELIVER DOSAGE WITHOUT COMPLICATION.