BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7434706 · Received April 16, 2018

    Report

    Report Number
    1213809-2018-00204
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    March 23, 2018
    Report Date
    May 7, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: PHOTO EVALUATION: FIVE PHOTOS WERE RECEIVED. THEY CONFIRM THE PACKAGES TO BE FROM BATCH # 6242511 (P/N # 309628). NO VISUAL DEFECTS WERE OBSERVED IN THESE PHOTOS. THEY SHOW MISSING PRINT ON TWO SYRINGES AND INK WHICH TRANSFERRED TO THE USER¿S THUMB. ONLY FEW LIMITED NUMBERS ON THE SCALE MARKINGS ARE AFFECTED IN THE PHOTOS. BASED ON THE PHOTOS PROVIDED AND THE COMPLAINT DESCRIPTION, THE MISSING PRINT OBSERVED IS A RESULT OF THE END USER MANIPULATION OF THE SAMPLES BY RUBBING THE PRINT OFF WITH THE THUMB. SAMPLE EVALUATION: FOUR LOOSE 1ML ASSEMBLED SYRINGE AND TWO EMPTY SYRINGE PACKAGES WERE RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #6242511 (P/N 309628). THE SAMPLES WERE VISUALLY EVALUATED. THREE OF THE SYRINGES WERE IDENTIFIED WITH A SAMPLE # (2, 3 AND 4). NO DEFECTS INCLUDING MISSING PRINT WERE OBSERVED. THE PRINT PERMANENCY TEST WAS PERFORMED USING THE ALCOHOL WIPE TEST - ALL THREE SAMPLES PASSED WITH NO SCALE MARKINGS COMING OFF. ONE SYRINGE WAS NOT IDENTIFIED WITH A SAMPLE #. MISSING PRINT WAS OBSERVED THROUGHOUT THE ENTIRE PRINTED SCALE. THIS SAMPLE MATCHED ONE OF THE PHOTOS INITIALLY PROVIDED AND REPORTED TO HAVE BEEN MANIPULATED BY THE USER. THE SAMPLE'S PRINT PERMANENCY COULD NOT BE TESTED DUE TO THE SAMPLE HAVING BEEN MANIPULATED AND THE SCALE COMPROMISED. THE PRODUCT IS INTENDED FOR SINGLE USE ONLY AND COMPLIES WITH ISO:7886-1 REQUIREMENTS. BASED ON THE EVIDENCE PROVIDED, THE DEFECT AS OBSERVED CANNOT BE ATTRIBUTED TO THE MANUFACTURING PROCESS BUT IS A RESULT OF USER MANIPULATION. 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. INVESTIGATION SUMMARY: BASED ON THE SAMPLES RECEIVED AND TESTING PERFORMED, THE REPORTED DEFECT COULD NOT BE VERIFIED. THE SCALE MARKINGS WERE CONFIRMED TO BE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: (B)(6). 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 GRADUATION MARKINGS WERE EASILY WIPED OFF ON A 1 ML BD LUER-LOK¿ DISPOSABLE SYRINGE BY A "SIMPLE STROKE OF A FINGER" MAKING THE MARKINGS ILLEGIBLE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277565 BD LUER-LOK¿ DISPOSABLE SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 6242511 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other