BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M COMPLY HYDROGEN PEROXIDE CHEMICAL INDICATOR 1248

    MDR report key: 24709342 · Received March 30, 2026

    Report

    Report Number
    MW5186041
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    March 19, 2026
    Report Date
    March 23, 2026
    Manufacturer
    SOLVENTUM US LLC / 3M COMPANY
    Product Code
    JOJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SINCE (B)(6) 2026, (B)(6) HAS OBSERVED REPEATED FAILURES OF THE 3M COMPLY HYDROGEN PEROXIDE CHEMICAL INDICATOR (1248) DURING STERILIZATION OF CONMED POWER BATTERIES AND ZIMMER SERIES X BATTERIES. AFTER PROCESSING IN STERRAD NX (NON LUMEN AND DUO CYCLES) AND V PRO MAX, INDICATORS FREQUENTLY RETAINED BLUE SPOTS RATHER THAN TURNING FULLY PINK AS SPECIFIED BY THE MANUFACTURER. FAILURES OCCURRED DESPITE VARYING PLACEMENT OF INDICATORS AND CONSISTENT USE OF BLUE STERILE WRAP. THE ONLY CONFIGURATION THAT PRODUCED A FULLY PINK INDICATOR WAS PLACING 1¿2 BATTERIES IN A PLASTIC CONTAINER, PLACING THE INDICATOR INSIDE THE CONTAINER, AND THEN BLUE WRAPPING THE CONTAINER. 3M DOCUMENTATION STATES THESE INDICATORS ARE VALIDATED FOR USE IN BOTH STERRAD NX AND V PRO MAX. CARMEN PINON HAS CONTACTED SOLVENTUM AND SPOKE WITH LAWRENCE TALAPA WHO PROVIDED POTENTIAL SOLUTIONS AND STATED THAT HE INPUT A PRODUCT COMPLIANT WITH SOLVENTUM. THE MAIN SOLUTION TOLD TO HER WAS TO PREWARM BATTERIES PRIOR TO STERILIZATION. INSTRUCTIONS FOR USE FOR THE INDICATOR AND STERRAD NX DO NOT HAVE ANY STATEMENTS REGARDING PREWARMING DEVICES PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769985 3M COMPLY HYDROGEN PEROXIDE CHEMICAL INDICATOR 1248 INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS JOJ SOLVENTUM US LLC / 3M COMPANY 1248

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other