BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURECAN SAFETY II

    MDR report key: 13500349 · Received February 9, 2022

    Report

    Report Number
    9612452-2022-00006
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    January 17, 2022
    Report Date
    August 3, 2022
    Manufacturer
    B. BRAUN MEDICAL FRANCE
    Product Code
    PTI
    UDI-DI
    04046964857737
    PMA / PMN Number
    K170897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER: (B)(4). WE HAVE CHECKED THE MANUFACTURING FILE OF BATCH: NR20F09G8670 WHICH COMPLIES WITH OUR SPECIFICATIONS AND DOES NOT PRESENT ANY DISCREPANCY. ANOTHER SIMILAR COMPLAINT FROM THE SAME END CUSTOMER HAS BEEN REPORTED TO US ON THIS BATCH OF 7000 NEEDLES RELEASED IN OCTOBER 2020. WITHOUT THE COMPLAINT SAMPLE FOR INVESTIGATION NO THOROUGH INVESTIGATION IS POSSIBLE AND WE CANNOT CONCLUDE ON THE REAL CAUSE OF THE INCIDENT. IF NEW ELEMENTS BECOME AVAILABLE IN THE FUTURE, WE WILL REOPEN THIS COMPLAINT. THIS TYPE OF INCIDENT IS A KNOWN RISK OF THE USE OF NEEDLES. THE SURECAN SAFETY II HAS A MANUALLY ACTIVATED SAFETY MECHANISM THAT IS DESIGNED TO DEPLOY UPON NEEDLE REMOVAL AND TO SHIELD THE TIP, TO REDUCE NEEDLESTICK INJURIES. SURECAN SAFETY II'S FEATURES INCLUDE A GREEN DOT, WHICH APPEARS THROUGH THE CLEAR BOTTOM PLATE WHEN THE SAFETY MECHANISM IS SUCCESSFULLY ENGAGED. REVIEWED THE DHR FOR THE BATCH NO. 20F09G8670, NO RELATED DEFECT WAS OBSERVED DURING THE IN-PROCESS AND FINAL CONTROL INSPECTION. BATCH SIZE: 7000 BATCH RELEASED DATE: 2020-10-16.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: "THE NEEDLE COVER WOULD NOT LOCK INTO PLACE RESULTING IN A NURSE GETTING STUCK WITH THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60300 SURECAN SAFETY II NON-CORING (HUBER) NEEDLE PTI B. BRAUN MEDICAL FRANCE 4447000-02 20F09G8670 04046964857737

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown