BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    MDR report key: 7237595 · Received February 2, 2018

    Report

    Report Number
    3003902955-2018-00003
    Event Type
    Malfunction
    Date Received
    February 2, 2018
    Report Date
    February 2, 2018
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K122249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: REQUESTED BUT UNKNOWN. UDI - NOT YET COVERED BY THE UDI IMPLEMENTATION CUT-OFF. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE - REQUESTED BUT NOT PROVIDED. THE ACTUAL DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURING FACILITY. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF THE USER FACILITY INFORMATION, AND THE RETENTION SAMPLES OF THE INVOLVED PRODUCT CODE/LOT NUMBER COMBINATION. VISUAL INSPECTION REVEALED NO DEFECTS. RETENTION SAMPLES WERE EVALUATED FOR CANNULA STIFFNESS AND RESISTANCE TO BREAKAGE AND ALL SAMPLES WERE COMPLIANT PER ISO 9626. A REVIEW OF THE LOT HISTORY FILES WAS CONDUCTED WITH NO FINDINGS. PRIOR TO SHIPMENT, QC CONDUCTS OUTGOING VISUAL, FUNCTIONAL AND SENSORY INSPECTIONS AND ALL SAMPLES FOR THE COMPLAINT LOT PASSED. THE INVESTIGATION RESULTS VERIFIED THAT THE RETENTION SAMPLE WAS THE NORMAL PRODUCT. WITHOUT THE RETURN OF THE ACTUAL DEVICE THE EXACT CAUSE CANNOT BE DEFINITELY DETERMINED. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (PHILIPPINES) CORPORATION (MANUFACTURER) REGISTRATION NO. 3003902955. EXEMPTION NUMBER E2015017.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE CONSUMER REPORTED THAT WHEN MEDICATION WAS INJECTED INTO HER ARM, THE NEEDLE BROKE OFF IN THE ARM. THE CONSUMER WAS NOT ABLE TO GET ANY MEDICATION. THE PHARMACIST REPORTED PLIERS HAD TO BE USED TO TAKE THE NEEDLE OUT OF THE PATIENT'S ARM. THE PHARMACIST REPORTED THE "NEEDLE BROKE AT THE PLASTIC PART". THERE WAS A BACKUP SUPPLY OF THE RISPERDAL CONSTA AND THEREFORE THE CONSUMER WAS ABLE TO GET THE SHOT. ADDITIONAL INFORMATION WAS RECEIVED ON 12/07/2017: CONSUMER REPORTED THAT THE NEEDLE BECAME DETACHED FROM THE LUER CONNECTION. CONSUMER DID NOT MENTION THAT IT REMAINED IN HER ARM. CONSUMER STATED THAT SHE HAS BEEN TAKING PRODUCT FOR 13 YEARS. CONSUMER REPORTED THE PRODUCT IS ADMINISTERED WEEKLY ON SUNDAY NIGHT OR MONDAY MORNING. THIS PAST MONDAY WHEN THE PRODUCT WAS ADMINISTERED THE CONSUMER REPORTED THAT THE NEEDLE SNAPPED. CONSUMER DID NOT CLARIFY WHERE THE NEEDLE SNAPPED. CONSUMER REPORTED THAT SHE WILL BE SHORT 2 DOSES FOR THE MONTH DUE TO THE TWO EXPERIENCES REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 12/8/2017: CONSUMER REPORTED THAT THE DELTOID NEEDLE BECAME DETACHED FROM THE LUER CONNECTION. CATEGORY WAS PREVIOUSLY INVESTIGATED THEREFORE, NO ADDITIONAL TRIAGE REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 1/12/2018: UPDATE PER JANSSEN: IT WAS REPORTED BY THE CONSUMER THAT THE CNA DID NOT NEED PLIERS TO REMOVE THE NEEDLE. THE CNA PULLED THE NEEDLE OUT OF THE CONSUMER'S HARM. CONSUMER STATED SHE IS NOT SURE IF THE CNA HIT HER MUSCLE BUT THE MEDICATION APPEARED TO HAVE COME BACK OUT. CONSUMER REPORTED THAT THE CNA STUCK THE NEEDLE IN HER ARM AND JUST AS THE CNA WAS PULLING THE NEEDLE OUT MOVED THE CNA MOVED TO LEFT A LITTLE AND THE NEEDLE JUST SNAPPED. CONSUMER STATED HER SHOTS ARE CRUCIAL. IT WAS REPORTED BY THE PHARMACIST, THAT THE CONSUMER REPORTED THE NEEDLE WAS IN HER ARM AND HAD TO BE REMOVED WITH PLIERS. IT WAS REPORTED BY THE CONSUMER, THAT THE STEEL OF THE NEEDLE BROKE. IT WAS REPORTED BY THE PHARMACIST THAT THE SYRINGE BROKE WHERE THE METAL STOPS (WHERE IT CONNECTS WITH THE PLASTIC PART). IT WAS REPORTED BY THE CONSUMER THAT THE LENGTH OF THE NEEDLE FROM THE LUER TO THE BREAKAGE WAS QUITE BIG. IT WAS REPORTED THAT THE NEEDLE WAS HALFWAY IN HER SHOULDER. CONSUMER STATED THIS WAS NEVER A PROBLEM BEFORE. IT WAS REPORTED BY THE PHARMACIST THAT IT BROKE RIGHT AT THE CONNECTION OF THE NEEDLE AND THE LUER. IT WAS REPORTED BY THE CONSUMER THAT SHE DOESN'T KNOW IF NEEDLE WAS BENT PRIOR TO BEING ADMINISTERED. IT WAS STATED THAT SHE STILL HAS A BRUISE FROM THIS EXPERIENCE. IT WAS REPORTED BY THE PHARMACIST THAT THE NEEDLE WAS NOT BENT PRIOR TO USAGE, IT CAME IN A SEALED KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80833 TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO PHILIPPINES CORPORATION N/A 160303D

    Patients

    Seq Age Sex Outcome Treatment
    1