ACTIVFLO ROUTINE I-TAPED- BLUE 1000

Additional Manufacturer Narrative

RETAIN SAMPLES WERE NOT AVAILABLE FOR FURTHER TESTING. THE ROOT CAUSE FOR "THE PLASTIC SEEMS QUITE FLIMSY, AND STAFF HAVE HAD ISSUES WITH THEM CLOSING PROPERLY" REPORTED BY THE CUSTOMER COULD NOT BE UNEQUIVOCALLY DETERMINED FROM THE INFORMATION AVAILABLE. ALTHOUGH THE INFORMATION AVAILABLE INDICATES THAT NO ADVERSE CONSEQUENCE(S) TO A PATIENT(S) HAS BEEN REPORTED TO THE MANUFACTURER, THE CIRCUMSTANCES INVOLVED IN THIS COMPLAINT HAVE PREVIOUSLY RESULTED IN SERIOUS INJURY. IF ADDITIONAL INFORMATION IS RECEIVED AN ADDITIONAL FOLLOW UP MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative

THE CUSTOMER REPORTED ACTIVFLO ROUTINE I-TAPED- BLUE 1000, P/N 39LC-500-2-L, LOT 20250307 SEEMED QUITE FLIMSY, AND STAFF HAVE HAD ISSUES WITH THEM CLOSING PROPERLY. NO ADVERSE EVENTS WERE REPORTED. TRENDING ANALYSIS FROM 15 OCT 2024 TO 15 OCT 2025 REPORTED NO (0) OTHER RELATED OCCURRENCES OF THIS ISSUE FOR THIS PRODUCT LOT. AS MANUFACTURER INVESTIGATION OF THIS COMPLAINT BY LEICA BIOSYSTEMS IS IN PROGRESS, THE ROOT CAUSE OF THIS EVENT HAS NOT YET BEEN DETERMINED.

Description of Event or Problem

ON 25 SEPTEMBER 2025, LEICA BIOSYSTEMS RECEIVED A COMPLAINT DETAILING "THE PLASTIC SEEMS QUITE FLIMSY, AND STAFF HAVE HAD ISSUES WITH THEM CLOSING PROPERLY." ON 18 OCTOBER 2025, THE LEICA ACCOUNT MANAGER ADVISED THE LEICA ASSOCIATE, QUALITY ASSURANCE THAT THE AWARENESS DATE FOR THIS EVENT WAS 21 AUGUST 2025.