BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURECAN SAFETY II

    MDR report key: 9765216 · Received February 27, 2020

    Report

    Report Number
    9612452-2020-00007
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Date of Event
    January 30, 2020
    Report Date
    February 27, 2020
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    PTI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). BATCH HISTORY REVIEW: THE EXACT BATCH NUMBER IS UNKNOWN. WE HAVE CHECKED THE MANUFACTURING FILES OF EVERY POTENTIAL BATCH THAT CAN BE INVOLVED IN THIS INCIDENT: LOT 18N12G8661 RELEASED ON : 2018-12-24, LOT 19A07G8670 RELEASED ON : 2019-01-24, LOT 19B07G8672 RELEASED ON : 2019-02-21, LOT 19B08G8672 RELEASED ON : 2019-02-21, LOT 19B09G8670 RELEASED ON : 2019-02-21, LOT 19B09G8671 RELEASED ON : 2019-02-21, LOT 18M14GA671 RELEASED ON : 2019-02-22, LOT 19B18G8660 RELEASED ON : 2019-02-28, LOT 19B18G8661 RELEASED ON : 2019-03-06, LOT 19C03G8673 RELEASED ON : 2019-03-20. THE BATCH HISTORY REVIEW SHOWS THAT: ALL OF THEM COMPLY WITH OUR SPECIFICATIONS AND DO NOT PRESENT ANY DISCREPANCY. FOR EVERY BATCH, NO OTHER SIMILAR COMPLAINT HAS BEEN REPORTED TO US. CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE ACTUAL SAMPLE A THOROUGH SAMPLE ANALYSIS COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. REVIEW OF THE DEVICE HISTORY RECORD PERFORMED FOR THE REPORTED LOT NUMBERS DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED. THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 1

    THE NURSE RECEIVED A NEEDLESTICK INJURY AS A RESULT OF THE PRODUCT NOT WORKING CORRECTLY. AS A RESULT OF THIS SHE HAD TO UNDERGO BLOOD TESTS TO ENSURE SHE WAS OKAY, AND FREE OF ANY CONTAGIOUS BLOOD BOURNE DISEASE. PATIENT ALSO HAD BLOOD TESTS TO ENSURE SHE WAS FREE OF ANY CONTAGIOUS BLOOD BOURNE DISEASE THAT COULD BE TRANSFERRED. THERE IS NO SAMPLE NEEDLE AVAILABLE, AS IT WAS DISPOSED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225672 SURECAN SAFETY II NON-CORING (HUBER) NEEDLE PTI B.BRAUN MEDICAL SAS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1