BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 8179189 · Received December 19, 2018

    Report

    Report Number
    1213809-2018-00908
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    December 4, 2018
    Report Date
    March 14, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO LOOSE CONVENIENCE TRAYS IN SEPARATE PLASTIC ZIP LOCK BAGS WERE RETURNED AND VISUALLY EVALUATED. ONE TRAY, REPORTED TO BE FROM BATCH #8211649, WAS EMPTY OF SYRINGES AND OBSERVED TO HAVE A LOOSE BLACK HAIR ON THE BOTTOM OF THE TRAY APPROXIMATELY 1¿ LONG ¿ LARGER THAN LEVEL 3 IN SIZE, WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. ONE TRAY, REPORTED TO BE FROM BATCH #8236598, WAS FILLED WITH 10ML SYRINGES. ONE SYRINGE WAS FOUND TO HAVE DAMAGED FLANGE AND SIDE OF THE BARREL. THE DAMAGE APPEARED TO HAVE SCRAPED PART OF THE FLANGE OFF, WHICH WAS STILL ATTACHED TO THE OPPOSITE SIDE OF THE FLANGE IN BALL OF FUZZY PLASTIC. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE 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 TWO PROVIDED LOT NUMBER(S) THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY A HAIR WAS FOUND INSIDE THE PACKAGING AND THE FLANGE WAS DAMAGED.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8211649. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-08-24. MEDICAL DEVICE LOT #: 8236598. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-09-04. 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 BEFORE USE OF THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY A HAIR WAS FOUND INSIDE THE PACKAGING AND THE FLANGE WAS DAMAGED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017122 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Other