BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 3ML SYRINGE WITH LUER-LOK¿ TIP WITH BLUNT PLASTIC CANNULA

    MDR report key: 9292671 · Received November 7, 2019

    Report

    Report Number
    1213809-2019-01119
    Event Type
    Malfunction
    Date Received
    November 7, 2019
    Date of Event
    October 23, 2019
    Report Date
    December 27, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903033462
    PMA / PMN Number
    K974363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SIX PHOTOS WERE RECEIVED AND EVALUATED. FOUR PHOTOS DISPLAYED THE MEDICATION VIAL FROM DIFFERENT ANGLES. TWO PHOTOS DISPLAYED A LOOSE 3ML SYRINGE WITH BLUNT CANNULA ATTACHED. IT WAS OBSERVED THERE WAS APPROXIMATELY 1ML OF CLEAR FLUID AND A SMALL RED FOREIGN MATTER PARTICULATE INSIDE THE SYRINGE. THE PARTICLE APPEARED TO BE A PIECE OF THE VIAL SEPTUM. NO DEFECTS WERE CONFIRMED WITH THE RETURNED PRODUCT. IT IS POSSIBLE THE PRODUCT WAS NOT USED WITH THE APPROPRIATE SEPTUM. PER PRODUCT SPECIFICATION BD® SYRINGE WITH BLUNT PLASTIC CANNULA PROVIDES STERILE NEEDLELESS ACCESS INTO: VIALS DESIGNED FOR NEEDLELESS ACCESS AND PRE-SLIT SEPTUM VIAL ADAPTERS FOR THE WITHDRAWAL AND MEASUREMENT OF FLUIDS. PRE-SLIT SEPTUM IV SYSTEMS FOR DISPENSING FLUIDS. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE PHOTOS RECEIVED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 3ML SYRINGE WITH LUER-LOK¿ TIP WITH BLUNT PLASTIC CANNULAS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303346 ; BATCH NO.: UNKNOWN. IT WAS REPORTED THAT WHEN THE NURSE PIERCED THE VIAL, A PIECE OF THE CORING FROM THE TOP OF THE VIAL WAS IN THE SYRINGE. VERBATIM: CUSTOMER CALLED IN WITH ISSUES REGARDING THE # 3033496 3ML SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 3ML SYRINGE WITH LUER-LOK¿ TIP WITH BLUNT PLASTIC CANNULAS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303346 BATCH NO.: UNKNOWN. IT WAS REPORTED THAT WHEN THE NURSE PIERCED THE VIAL, A PIECE OF THE CORING FROM THE TOP OF THE VIAL WAS IN THE SYRINGE. VERBATIM: CUSTOMER CALLED IN WITH ISSUES REGARDING THE # 3033496 3ML SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083342 BD 3ML SYRINGE WITH LUER-LOK¿ TIP WITH BLUNT PLASTIC CANNULA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903033462

    Patients

    Seq Age Sex Outcome Treatment
    1 Other