MINI SPIKE DISP PIN

Description of Event or Problem

PATIENT REPORTS THAT SHE HAS HAD AN ISSUE WITH A FEW SPIKES. DOES NOT HAVE LOT NUMBER. STATES DRUG LEAKED THROUGH VENT PART OF THE SPIKE ONE TIME, AND ANOTHER INSTANCE SHE HAD A SPIKE THAT SHE STATES SHE WASTED A LOT OF DRUG BECAUSE SHE WAS NOT ABLE TO GET DRUG OUT OF THE VIAL WITH THE SPIKE SHE HAD. PRODUCT LOT NUMBER AND EXPIRATION DATE ARE UNKNOWN. UNKNOWN IF PATIENT MISSED DOSE OR EXPERIENCED ADVERSE EVENT. UNKNOWN IF PATIENT HAS PRODUCT ON HAND. DATE OF PRODUCT COMPLAINT IS UNKNOWN. NO OTHER INFORMATION KNOWN. REPORTED TO (B)(6) BY: PATIENT/CAREGIVER. REFERENCE REPORT: #MW5149720.