PEGINTRON REDIPEN 150 UG/0.5 ML
Received Jul 10, 2014 · Event occurred May 27, 2014
Report MW5037890 · MDR key 4037543
Device
Product problems
- Chemical Spillage
- Noise, Audible
Patient
Not reported
- Chemical Exposure
Narrative
Description of Event or Problem
ON (B)(6) 2014, MERCK WAS NOTIFIED ABOUT A CUSTOMER COMPLAINT CONCERNING PEGINTRON REDIPEN. THE COMPLAINT CONCERNED A PHARMACY TECH WHO REPORTED THAT "A PT'S PEGINTRON REDIPEN" EJECTED ALL OF THE MEDICATION FROM THE BACK OF THE PEN ONTO THE PT'S HAND AND ARM". THIS WAS WHEN THE PT HAD PLACED THE NEEDLE INTO THE INSERTION SITE AND ATTEMPTED TO PUSH DOWN ON THE DOSING BUTTON. THE PT HAD HEARD A "CRACK" SOUND AND THAT IS WHEN THE MEDICATION EJECTED ALL OF THE MEDICATION. THIS MEDICATION DID NOT GO INTO THE PT AT ALL". NO COMPLAINT SAMPLE WAS RETURNED. THE PEN COULD THEREFORE NOT BE EXAMINED TO VERIFY WHETHER A DEFECT WAS PRESENT. THE REPORTED LOT NUMBER OF THE COMPLAINT WAS (B)(4) AND THE EXPIRY DATE WAS JULY 2015. (B)(4).