MULTIPLE ATTEMPTS TO OBTAIN THE SAMPLE, HOWEVER THE SUBJECT PRODUCT WAS NOT RETURNED FOR EVALUATION WERE MADE. WITHOUT THE SUBJECT PRODUCT OR ADDITIONAL INFORMATION, A DEFINITIVE CONCLUSION AS TO WHEN/HOW THE GLASS VIAL WAS DAMAGED CANNOT BE DETERMINED. IF THE SAMPLE IS RETURNED OR ADDITIONAL INFORMATION IS RECEIVED, THIS FILE WILL BE UPDATED. THE IFU FOR THE PROGEL INSTRUCTS THE USER: IF PACKAGE AND/OR PRODUCT INTEGRITY HAVE BEEN COMPROMISED, (I.E., DAMAGED PACKAGE SEAL, OR BROKEN GLASS) DO NOT USE OR RE-STERILIZE THE CONTENTS. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. A REVIEW OF THE SUBJECT LOT FOUND THIS TO BE THE FIRST COMPLAINT REPORTED FOR THE 464 UNITS RELEASED TO STOCK IN (B)(6) 2018. DEVICE REQUESTED, BUT NOT RETURNED.
D
Patient 1
IT WAS REPORTED THAT ONE PROGEL KIT HAD A BROKEN GLASS VIAL INSIDE THE KIT WHEN IT WAS OPENED. THE CONTACT REPORTED THAT THERE WAS NO DAMAGE NOTED ON THE OUTER BOX OR THE OUTER SHIPPING CARTON WHEN IT WAS RECEIVED. THE PROBLEM WAS NOTED WHEN OPENED DURING THE CASE. THE BROKEN GLASS WAS NOTED INSIDE ONE OF THE PRE-LOADED CARTRIDGES. THE CONTACT CONFIRMED THAT THERE WAS NO LOOSE GLASS IN THE PACKAGE. THIS CONDITION WAS FOUND IN PREPARATION FOR USE AND NOT ON THE STERILE FIELD. THERE WAS NO PATIENT INVOLVEMENT.