BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 8683750 · Received June 10, 2019

    Report

    Report Number
    1213809-2019-00604
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 24, 2019
    Report Date
    July 17, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO WAS RECEIVED AND EVALUATED. THE PHOTO DEPICTED AN OPENED BLISTER PACKAGE FROM BATCH #9003651 (P/N 300912) AND A LOOSE 10ML SYRINGE. THE SYRINGE WAS OBSERVED TO HAVE A LENGTHWISE CRACK IN THE BARREL LOCATED APPROXIMATELY BETWEEN 3ML TO 10ML MARKINGS OUTSIDE THE PRINTED SCALE. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 10ML SYRINGE LUER-LOK¿ TIP HAD A CRACK ON THE SYRINGE BODY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 SYRINGES OF THE SAME BATCH FOUND WITH A CRACK ON THE BODY OF THE SYRINGE CAUSING A LEAK. THEY WERE USED FOR THE SAMPLE OF SOLVENTS (0.9% NACL AND PPI WATER).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (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 10 ML SYRINGE LUER-LOK¿ TIP HAD A CRACK ON THE SYRINGE BODY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2 SYRINGES OF THE SAME BATCH FOUND WITH A CRACK ON THE BODY OF THE SYRINGE CAUSING A LEAK. THEY WERE USED FOR THE SAMPLE OF SOLVENTS (0.9% NACL AND PPI WATER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479053 BD 10ML SYRINGE LUER-LOK TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9003651 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other