Description of Event or Problem · 1
IT WAS REPORTED TO AMS THAT A POTENTIALLY UNSEALED POUCH WAS DETECTED WITHIN A HOSPITAL IN (B)(6) AND REPORTED TO AMS ON THE 11TH JANUARY 2021. INITIAL COMPLAINANT ENCLOSED A PCITURE AND DECLARED THAT SAMPLES WERE AVAILBLE TO REVIEW. AT THAT TIME THE COMPLAINT WAS UNVERFIED AS THE INCIDENT PICTURES COULD NOT DEFINITEVELY IDENTIFY THE ISSUE AS BEING AN UNSEALED POUCH VERSUS AN OPENED POUCH. UPON FURTHER REVIEW OF THIS COMPLAINT AND RECEIPT OF THE SAMPLES ON 11TH FEBRUARY 2021 IT WAS DETERMINED THAT THERE WAS A SEGMENT OF ANOTHER DRESSING CAUGHT IN THE SEAL WHICH HAD PREVENTED THE SEALING OF THAT PART OF THE POUCH AND AS SUCH THE ORIGINAL COMPLAINT WAS VERIFIED. AND THAT THE DEFECT WAS NOT A SEAL FAILURE DURING PACKAGING BUT WAS A DEFECT CAUSED BY ANOTHER DRESSING BEING CAUGHT WITHIN THE SEAL AND AS A RESULT, THE POUCH HAD BEEN SLIT OPEN DURING THE PACKAGING PROCESS AND SUBSEQUENTLY WAS NOT REJECTED DURING X-RAY DETECTION DURING THE PACKAGING PROCESS. DESPITE SUBSEQUENT STERILISATION THE PACKAGE WOULD HAVE REMAINED OPEN AND AS SUCH THE DRESSING WOULD REMAIN EXPOSED AND THEREFORE IS LIKELY TO BE NON-STERILE AND A POTENTIAL MICROBIAL RISK TO PATIENTS. DESPITE THIS PACKAGING MALFUNCTION, THE ISSUE WAS DETECTED PRIOR TO USE AND THEREFORE THERE WAS NO DIRECT IMPACT TO PATIENT IN THIS INCIDENT. IF THE MALFUNCTION WAS TO RECUR, DUE TO THE NATURE OF THE DEFECT IT HAS POTENTIAL TO NOT BE DETECTED BY CLINICIANS AND END USERS AND AS SUCH THE DEVICE MAY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR DUE TO THE LOSS OF STERILITY AND POTENTIAL EXPOSURE TO INFECTIOUS AGENTS.