LEUKOSTRIP 13X102MM CTN 50

Description of Event or Problem

IT WAS REPORTED THAT, DURING SET UP OR INSPECTION BEFORE USE, IT WAS CONFIRMED THERE WAS A FOREIGN SUBSTANCE IN THE STERILE POUCH. A BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF THERE WAS A DELAY. NO INJURY OR OTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE: (B)(4).

Additional Manufacturer Narrative

H3, H6: THE PRODUCT HAS BEEN RETURNED AND EVALUATED, THE EVENT IS CONFIRMED. VISUAL INSPECTION OF THE DRESSING HAS CONFIRMED THE REPORTED CONTAMINATION, THIS HAS BEEN CONFIRMED TO BE ADDITIONAL ADHESIVE, THIS IS NOT ANY OTHER FORM OF CONTAMINATION. A DOCUMENTATION REVIEW HAS REVEALED PREVIOUSLY CASES WITH A SIMILAR NATURE, THERE ARE NO OPEN CORRECTIVE ACTIONS. THE MANUFACTURING RECORDS CONFIRM THE DEVICE MET THE FINAL PRODUCT SPECIFICATIONS AND CONTAIN NO CONTRIBUTORY FACTORS TO THE REPORTED EVENT, A REVIEW OF THE MANUFACTURING PROCESS HAS REVEALED THE PROBABLE ROOT CAUSE. THE ASSOCIATED RISK FILES MITIGATE THIS EVENT TYPE. A PROBABLE ROOT CAUSE IS RELATED TO TRAINING, THE CONTAMINATION, IS ADDITIONAL ADHESIVE, WHICH CAN BE FOUND ON THE RAW MATERIAL. THIS, ONCE LOCATED SHOULD BE PICKED OUT PREVENTING THIS FROM REACHING THE PRODUCT MARKET. RETRAINING HAS BEEN CONDUCTED TO REDUCE THE PROBABILITY OF FUTURE OCCURRENCES. NO CORRECTIVE ACTIONS ARE DEEMED NECESSARY, AT THIS STAGE, SMITH AND NEPHEW WILL CONTINUE TO MONITOR FOR ADVERSE TRENDS RELATING TO THE REPORTED EVENT.