BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML SURESCRUB POSIFLUSH SALINE

    MDR report key: 8579783 · Received May 3, 2019

    Report

    Report Number
    1911916-2019-00441
    Event Type
    Malfunction
    Date Received
    May 3, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 20, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065593
    PMA / PMN Number
    K161552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYR 10ML SURESCRUB POSIFLUSH SALINE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306559 BATCH NO: 8261703 EVENT DESCRIPTION PER ATTACHED EMAIL STATES, "WE HAD A SALINE FLUSH TODAY, SAME LOT 8261703, IN WHICH THE SALINE CAME OUT TOWARD THE NURSES BY THE PLUNGER END. WE WILL ENTER AN SI, BUT WANTED TO LET YOU ALL KNOW AS WELL. "

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: NGT, LKB. PMA/510(K)#: K161552, K121655. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYR 10ML SURESCRUB POSIFLUSH SALINE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306559, BATCH NO: 8261703. EVENT DESCRIPTION PER ATTACHED EMAIL STATES, "WE HAD A SALINE FLUSH TODAY, SAME LOT 8261703, IN WHICH THE SALINE CAME OUT TOWARD THE NURSES BY THE PLUNGER END. WE WILL ENTER AN SI, BUT WANTED TO LET YOU ALL KNOW AS WELL. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372291 SYR 10ML SURESCRUB POSIFLUSH SALINE SALINE, VASCULAR ACCESS FLUSH; PAD, ALCOHOL, DEVICE DISINFECTANT NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8261703 30382903065593

    Patients

    Seq Age Sex Outcome Treatment
    1 Other