Description of Event or Problem · 1
SAFETY ISSUE WITH THE MECHANISM OF THE SAFETY FEATURE OF THE TKMD SAFETY NEEDLE USED FOR THE COVID-19 VACCINES. PFIZER-BIONTECH PROVIDES ANCILLARY KITS ALONG WITH THE COVID-19 VACCINES. NO PATIENT HARM AND FOLLOWING PSRS SUBMITTED PSR-1444385 PSR-1444699. IN ADDITION TO THE ABOVE SUMMARY, MR. (B)(6) VERIFIED THAT THIS NEEDLE IS PART OF THE PFIZER ANCILLARY SUPPLY KIT, CDC PURCHASE ORDER # (B)(4). HE ALSO VERIFIED THAT THE PROBLEM WITH THE NEEDLE WAS THAT ¿THE SAFETY MECHANISM OF THE NEEDLE COULD POTENTIALLY CAUSE NEEDLE STICK INJURIES DUE TO THE WAY THE CAP FOR THE NEEDLE HAS TO BE ACTIVATED. WHEN PUSHING THE CAP TOWARDS THE NEEDLE, IF THE VACCINATOR IS NOT CAREFUL, THE CAP COULD SLIP TO THE SIDE (AND NOT STRAIGHT TOWARDS THE NEEDLE) AND CAUSE THE VACCINATOR'S FINGER TO GO STRAIGHT TO THE NEEDLE INSTEAD.¿ THERE WERE T INCIDENTS WHERE STAFF EXPERIENCED NEEDLE STICKS. PSRS WERE SUBMITTED FOR EACH INCIDENT AND AN AFTER ACTION REPORT WAS PROVIDED. HE ALSO VERIFIED THAT THE FACILITY IMPLEMENTED THE RECOMMENDATIONS FROM THE DHA AFTER ACTION REPORT. HE STATED THAT A SAFETY STAND DOWN WAS CONDUCTED FOR THE STAFF. HE REPORTED THAT ALL INDIVIDUALS USING THIS NEEDLE HAVE BEEN PROPERLY TRAINED IN THE USE OF THE NEEDLE AND THERE HAVE BEEN NO NEEDLE STICKS SINCE THE IMPLEMENTATION OF THE SAFETY STAND DOWN. THE FOLLOWING PICTURES OF THE NEEDLE HAVE BEEN PROVIDED. (U/FOUO/C/S) OBSERVATION: TWO NEEDLE STICK INJURIES HAVE OCCURRED FROM THE ANCILLARY KIT RECENTLY RECEIVED. (U) DISCUSSION: WHILE HUMAN ERROR MAY BE A CONTRIBUTING FACTOR IN THE RECENT NEEDLE STICK INJURIES, THE SAFETY FEATURE OF THE NEEDLE APPEARS TO BE FAULTY AS WELL. ACTIVATING THE SAFETY FEATURE AFTER VACCINATION COULD DEFINITELY CAUSE A NEEDLE STICK INJURY IF NOT DONE WITH PRECISION.