BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 9395847 · Received December 2, 2019

    Report

    Report Number
    1213809-2019-01195
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    October 28, 2019
    Report Date
    December 31, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PHOTO AND TWO 1ML SYRINGES INSIDE AN OPENED BLISTER PACK FROM BATCH 9170695 (P/N 309628) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED IN THE PHOTO AND ONE PHYSICAL SAMPLE THE STOPPER WAS SEPARATED FROM THE PLUNGER ROD AND WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE STOPPER SEPARATION DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9170695 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD LUER-LOK¿ TIP SYRINGES BROKE WHILE DRAWING UP "CODE DOSE MEDICATIONS" OF "EPINEPHRINE" DURING AN EMERGENCY BEDSIDE RESPONSE; THE STOPPERS HAD SEPARATED FROM THEIR RESPECTIVE PLUNGERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING EMERGENCY BEDSIDE RESPONSE TO PATIENT IN UNIT PICU/C5 THERE WERE 3 BD 1 ML SYRINGES THAT BROKE IN DRAWING UP CODE DOSE MEDICATIONS OF EPINEPHRINE WHERE THE WHITE PLUNGER BROKE FROM THE BLACK RUBBER PLATFORM INSIDE THE SYRINGES."

    Additional Manufacturer Narrative · 1

    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 3 BD LUER-LOK¿ TIP SYRINGES BROKE WHILE DRAWING UP "CODE DOSE MEDICATIONS" OF "EPINEPHRINE" DURING AN EMERGENCY BEDSIDE RESPONSE; THE STOPPERS HAD SEPARATED FROM THEIR RESPECTIVE PLUNGERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING EMERGENCY BEDSIDE RESPONSE TO PATIENT IN UNIT PICU/C5 THERE WERE 3 BD 1 ML SYRINGES THAT BROKE IN DRAWING UP CODE DOSE MEDICATIONS OF EPINEPHRINE WHERE THE WHITE PLUNGER BROKE FROM THE BLACK RUBBER PLATFORM INSIDE THE SYRINGES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194062 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9170695 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other