BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    MDR report key: 15901763 · Received December 2, 2022

    Report

    Report Number
    3003902955-2022-00057
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Report Date
    December 1, 2022
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CATALOG NUMBER: POTENTIAL LOTS: 1) SG3+2151, 2) SG3+2238, & 3) SG3+2325. LOT NUMBER: POTENTIAL LOTS: 1) 211021C, 2) 210930C, & 3) 211002C. EXPIRATION DATE: POTENTIAL DATES: 1) 30-SEP-2026, 2) 31-AUG-2026, 3) 30-SEP-2026. UDI: POTENTIAL DATES: 1) 34806017509270, 2) 34806017509669 & 3) 34806017509263. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE: POTENTIAL DATES: 1) 21-OCT-2021, 2) 30-SEP-2021, 3) 02-OCT-2021. PMA/510(K): POTENTIALS: K113422 (SG3+2151 AND SG3+2238) & K122249 (SG3+2325). THE ACTUAL SAMPLE WAS NOT AVAILABLE FOR OUR EVALUATION HENCE WE COULD NOT DETERMINE THE DETAILS OF ITS ACTUAL CONDITION. RETENTION SAMPLES WERE VISUALLY INSPECTED AND CONFIRMED FREE FORM BURR/BENT, DAMAGE NEEDLE TIP, FOREIGN MATERIAL, SCRATCH, BENT CANNULA, OR ANY CONTRIBUTING DEFECTS THAT WOULD LEAD TO THE COMPLAINT. WE HAVE RECEIVED TWO (2) COMPLAINTS COVERING FY20 TO FY22 (APRIL 2020 TO NOVEMBER 15, 2022) RELATED TO THIS ISSUE WHERE THE CAUSE WAS NOT IDENTIFIED RELATED TO OUR PRODUCT AND PRODUCTION PROCESS. THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE IDENTIFIED TO BE RELATED TO OUR PRODUCT OR PRODUCTION PROCESS. THERE WAS NO SERIOUS INJURY REPORTED OR ANY BACTERIAL INFECTION THAT OCCUR FROM THE EVENT. THE PATIENT HAD A PENNY SIZED BUBBLE AT THE INJECTION SITE. RETENTION SAMPLES WERE VISUALLY INSPECTED AND CONFIRMED FREE FROM ANY CONTRIBUTING DEFECTS THAT WOULD LEAD TO THE COMPLAINT. WE CHECK THE PRESENCE OF BACTERIAL ENDOTOXIN IN OUR PRODUCTS FOR EVERY LOT. THIS IS TO ENSURE THAT OUR FINISHED PRODUCTS ARE SAFE FOR USE AND WOULD NOT CAUSE HARM TO THE PATIENT. WE ALSO HAVE PHYSICOCHEMICAL TEST CONDUCTED MONTHLY TO CHECK THE TRACES OF METALS AND ALKALINE. ALL FINISHED PRODUCTS ARE STERILIZED THROUGH THE ELECTRON BEAM STERILIZATION PROCESS, AND IT IS ALSO PYROGEN-FREE AND DOES NOT CONTAIN ANY SUBSTANCE THAT MAY CAUSE FEVER WHEN INJECTED INTO THE BLOODSTREAM. FURTHERMORE, QC CONDUCTS AN OUTGOING VISUAL AND SENSORY INSPECTIONS TO CHECK THE CONDITION OF THE PRODUCTS BEFORE SHIPMENT. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (PHILIPPINES) CORPORATION (MANUFACTURER) REGISTRATION NO. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE PATIENT HAS BEEN ON THE ABILIFY INJECTION FOR ABOUT 5-6 YEARS AND HADN'T HAD A PROBLEM UNTIL HE GOT THE LAST SHOT DAYS AGO. THREE (3) DAYS LATER A PENNY SIZED BUBBLE FORMED AT THE INJECTION SITE AND WAS HURTING BADLY. THE PATIENT STATED THAT IT'S USUALLY A LITTLE PAINFUL BUT NOT AS PAINFUL AS THIS TIME. THE AREA IS STILL THERE AND ONLY AT THE INJECTION SITE, THE PAIN HAS GOTTEN WORSE. THE EVENT OCCURRED INTRA-PROCEDURE. THERE WAS NO BLOOD LOSS. THERE IS NOT A DIRECT ALLEGATION THAT THE REPORTED DEVICE CAUSED OR CONTRIBUTED TO PATIENT INJURY AND/OR NEED FOR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398794 TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO PHILIPPINES CORPORATION N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Male