BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP

    MDR report key: 8765220 · Received July 5, 2019

    Report

    Report Number
    1213809-2019-00705
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    June 18, 2019
    Report Date
    June 21, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: TWO PHOTOS OF A TOTAL OF 22 LOOSE 10ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED MOST OF THE SYRINGES HAD SIGNIFICANT DAMAGE INCLUDING BROKEN AND DEFORMED BARRELS AND PLUNGER RODS. SOME BARRELS HAVE THE PLUNGER RODS IN THE BOTTOM OUT POSITION AND SOME ARE PULLED OUT AT VARYING HEIGHTS. FURTHERMORE, 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 CONCLUSION: IT WAS OBSERVED MOST OF THE SYRINGES HAD SIGNIFICANT DAMAGE INCLUDING BROKEN AND DEFORMED BARRELS AND PLUNGER RODS. SOME BARRELS HAVE THE PLUNGER RODS IN THE BOTTOM OUT POSITION AND SOME ARE PULLED OUT AT VARYING HEIGHTS. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE MACHINE THESE SYRINGES WERE MANUFACTURED ON HAS A REJECTION FEATURE FOR HIGH PLUNGER RODS. IF ONE OF THE SYRINGES WAS IMPROPERLY REJECTED IT COULD HAVE BECOME JAMMED IN THE DIAL. THE RESULT MAY CAUSE A TEMPORARY AND SELF-CORRECTING JAM. DUE TO THE SMALL NUMBER OF DEFECTS AND NO OTHER COMPLAINTS RELATED COMPLAINTS FOR THIS BATCH, IT WAS MOST LIKELY AN ISOLATED DEFECT AND WAS ABLE TO ESCAPE DETECTION. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE EITHER DEFECTIVE RATE IDENTIFIED. BATCH 8303979 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE BD 10ML SYRINGES LUER-LOK¿ TIP WERE FOUND DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "MY PRODUCTION DEPARTMENT WARNS ME OF THE PRESENCE OF DEFORMED AND THEREFORE UNUSABLE 301029 SYRINGES, 22 SYRINGES ON LOT 8303979."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559312 BD 10ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8303979

    Patients

    Seq Age Sex Outcome Treatment
    1 Other