BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7768796 · Received August 9, 2018

    Report

    Report Number
    1213809-2018-00530
    Event Type
    Malfunction
    Date Received
    August 9, 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 1 OPENED PACKAGED 1ML LL SYRINGE WERE RECEIVED, CONFIRMED TO BE FROM BATCH #4071055 (P/N 309628). THEY WERE VISUALLY EVALUATED. THE 10 SEALED SYRINGES HAD NO VISUAL DEFECTS. THE 1 SYRINGE IN THE OPENED PACKAGE HAD FAINT BUT STILL VISIBLE AND LEGIBLE SCALE AROUND THE MID-CENTER OF THE GRADUATED MARKINGS, PRESUMABLY WHERE IT WAS RUBBED BY THE END-USER. NO DEFECTS WERE OBSERVED. THE 10 SEALED SYRINGES WERE TESTED FOR PRINT PERMANENCY PER PROCEDURE. ALL 10 SYRINGES PASSED WITH THE TEST WITH NO INK COMING OFF. THE REPORTED DEFECT WAS NOT CONFIRMED IN THE SAMPLES RECEIVED. THIS PRODUCT IS LABELED FOR SINGLE USE ONLY. IT IS NOT INTENDED FOR REPEATED INTENTIONAL MANIPULATION OF THE PRINTED SCALE. THE REPORTED DEFECT WAS NOT CONFIRMED IN THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE 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 BD LUER-LOK DISPOSABLE SYRINGE HAD BAD SCALE MARKING THAT EASILY RUBS OFF, AND THE PLUNGER IS LOOSE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 4071055; MEDICAL DEVICE EXPIRATION DATE: 2019-02-28; DEVICE MANUFACTURE DATE: 2014-03-28. MEDICAL DEVICE LOT #: 5240555; MEDICAL DEVICE EXPIRATION DATE: 2020-08-31; DEVICE MANUFACTURE DATE: 2015-10-08. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ DISPOSABLE SYRINGE HAD BAD SCALE MARKING THAT EASILY RUBS OFF, AND THE PLUNGER IS LOOSE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607544 BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other