BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7784902 · Received August 15, 2018

    Report

    Report Number
    1213809-2018-00531
    Event Type
    Malfunction
    Date Received
    August 15, 2018
    Date of Event
    July 25, 2018
    Report Date
    September 10, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: YES. 10 SEALED PACKAGED 1ML LL SYRINGES AND 2 OPENED PACKAGED 1ML LL SYRINGE WERE RECEIVED, CONFIRMED TO BE FROM BATCH #5240555 (P/N 309628). THEY WERE VISUALLY EVALUATED. THE 10 SEALED SYRINGES HAD NO VISUAL DEFECTS. 1 SYRINGE IN THE SECOND OPENED PACKAGE HAD NO VISUAL DEFECTS. THE PLUNGER HAD NO DEFECTS AS WELL. 1 SYRINGE IN AN OPENED PACKAGE HAD ALMOST NO PRINT ON THE BARREL. SOME SCALE MARKING RESIDUE WAS OBSERVED NEAR THE ZERO LINE WHICH COULD BE EASILY WIPED OFF. THE BARREL APPEARS TO HAVE BEEN MANIPULATED. ACCORDING TO VERBATIM, THE SCALE WAS ATTEMPTED TO BE WIPED OFF . ACCORDING TO VERBATIM, THE COMPLAINT APPEARS TO BE FOR THE ABSENCE OF RETENTION RING IN THE SYRINGE BARREL. THIS PRODUCT DOES NOT HAVE A RETENTION RING BY DESIGN ACCORDING TO ITS PRODUCT SPECIFICATION. THE DESIGN OF THE PRODUCT HAS NOT CHANGED SINCE (B)(6) 2008 WHEN THE PRODUCT WAS FIRST INTRODUCED. THE REPORTED DEFECTS WERE NOT CONFIRMED IN THE SAMPLES RECEIVED. DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE TWO PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. .

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER COMES OUT TOO EASILY FROM THE SYRINGE OF THE BD LUER-LOK DISPOSABLE SYRINGE. THERE IS ALSO AN ISSUE OF THE SCALE DISAPPEARS WHEN THE SYRINGE IS RUBBED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5240555, MEDICAL DEVICE EXPIRATION DATE: 2020-08-31, DEVICE MANUFACTURE DATE: 2015-10-08. MEDICAL DEVICE LOT #: 4071055, MEDICAL DEVICE EXPIRATION DATE: 2019-02-28, DEVICE MANUFACTURE DATE: 2014-03-28. 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 PLUNGER COMES OUT TOO EASILY FROM THE SYRINGE OF THE BD LUER-LOK¿ DISPOSABLE SYRINGE. THERE IS ALSO AN ISSUE OF THE SCALE DISAPPEARS WHEN THE SYRINGE IS RUBBED. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627167 BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other