BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 8025291 · Received October 31, 2018

    Report

    Report Number
    1213809-2018-00712
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 12, 2018
    Report Date
    January 9, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO AND ONE PHYSICAL SAMPLE DEPICTED IN THE PHOTO WERE RECEIVED AND EVALUATED. THE SAMPLE WAS FROM AN UNKNOWN BATCH, EITHER 6082996 OR 6089725, P/N 301029, AS REPORTED AND MARKED ON THE SAMPLE BAG. THE SAMPLE HAD OBVIOUS SIGNS OF USE AND CONTAMINATION. FLUID RESIDUE WAS OBSERVED THROUGHOUT THE FLUID PATH WITH THE PLUNGER DRAWN PAST THE 10ML MARK. A MINOR DAMAGE TO THE PLUNGER ROD RETAINING RING WAS OBSERVED IN THE SAMPLE. POTENTIAL ROOT CAUSE FOR THE DAMAGED PLUNGER ROD DEFECT IS ASSOCIATED WITH THE MATERIAL HANDLING OR ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED (TWO) LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE LUER-LOK¿ TIP HAD HOLES IN THE PLUNGER AND LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6082996; MEDICAL DEVICE EXPIRATION DATE: 2021-02-28; DEVICE MANUFACTURE DATE: 2016-03-22. MEDICAL DEVICE LOT #: 6089725; MEDICAL DEVICE EXPIRATION DATE: 2021-03-31; DEVICE MANUFACTURE DATE: 2016-03-29. 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 SYRINGE LUER-LOK¿ TIP HAD HOLES IN THE PLUNGER AND LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862909 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other