BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML SURESCRUB POSIFLUSH SALINE

    MDR report key: 8667645 · Received June 4, 2019

    Report

    Report Number
    1911916-2019-00558
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 20, 2019
    Report Date
    June 18, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065593
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO WAS PROVIDED. IT SHOWS A SYRINGE IN ITS SEALED PACKAGING FLOW WRAP. THE ALCOHOL PAD LOOKS WET. FROM THE PHOTO WE CAN¿T CONFIRM HOW THE LEAKAGE OCCURRED AND IF ANY BARREL DAMAGE INDUCED IT. ROOT CAUSE IS UNDETERMINED. 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 LEAKED IN THE SEALED PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LIQUID LEAKED/EXPLODED"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: ALCOHOL PAD, DEVICE DISINFECTANT, MEDICAL DEVICE TYPE: LKB. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K161552, PMA / 510(K)#: K121655. DEVICE EVALUATED BY MFR: 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 LEAKED IN THE SEALED PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LIQUID LEAKED/EXPLODED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461529 SYR 10ML SURESCRUB POSIFLUSH SALINE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 8261704 30382903065593

    Patients

    Seq Age Sex Outcome Treatment
    1 Other