BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE (SHORT SHEATH)

    MDR report key: 12639179 · Received October 15, 2021

    Report

    Report Number
    3003902955-2021-00052
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    August 19, 2021
    Report Date
    October 15, 2021
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    UDI-DI
    34806017509713
    PMA / PMN Number
    K122249
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW-UP NO. 1 TO REPORT THAT THIS REPORTED EVENT HAS BEEN REASSESSED AND DEEMED NOT A REPORTABLE COMPLAINT BASED UPON AN INTERNAL REVIEW. THIS REPORTED ISSUE HAS BEEN CONFIRMED TO HAVE ALREADY BEEN COVERED UNDER AN EXISTING DAMAGE TO PACKAGE INVESTIGATION. THE LOT WAS NOT SHIPPED TO THE CUSTOMER BUT WAS DISCOVERED AND TRAPPED DURING THE 100% PRODUCT INSPECTION, WHICH IS ONE OF OUR CORRECTIONS FOR THIS ISSUE. FOR THE DAMAGE TO PACKAGE INVESTIGATION, PLEASE SEE MDR 3003902955-2021-00044.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: NO PATIENT INVOLVEMENT, AGE & DATE OF BIRTH: NO PATIENT INVOLVEMENT, PATIENT SEX: NO PATIENT INVOLVEMENT, WEIGHT: NO PATIENT INVOLVEMENT, ETHNICITY: NO PATIENT INVOLVEMENT, RACE: NO PATIENT INVOLVEMENT, OPERATOR OF DEVICE: NA, IMPLANTED DATE: DEVICE WAS NOT IMPLANTED, EXPLANTED DATE: DEVICE WAS NOT EXPLANTED, HEALTH PROFESSIONAL: UNKNOWN, OCCUPATION: SUPPLIER QUALITY SPECIALIST. BASED ON THE AVAILABLE INFORMATION AND THE RESULTS OF OUR INVESTIGATION, THE COMPLAINT IS POSSIBLY A SLIP THROUGH DURING THE 100% VISUAL INSPECTION FOR DAMAGE TO THE PACKAGE. PERFORMANCE TESTING OF SHIPPING CONTAINERS WAS CONDUCTED DURING VALIDATION OF THE BLISTER PACKAGING TO EVALUATE THE INTEGRITY OF THE PACKAGED PRODUCTS AS THE PRODUCT GOES THROUGH SHOCKS AND STRESSES NORMALLY ENCOUNTERED DURING HANDLING AND TRANSPORTATION. THE VERIFICATION OF THE PACKAGE PERFORMANCE WAS CONDUCTED LAST AUGUST 20, 2021 THROUGH AN ENGINEERING TEST REPORT. THE PRODUCT HAS UNDERGONE SIMULATED SHOCKS AND STRESSES WHICH ARE NORMALLY ENCOUNTERED DURING HANDLING AND TRANSPORTATION OF PRODUCTS UNTIL IT REACHES THE END-USER. BASED ON THE RESULTS OF THE SHIPPING AND HANDLING TEST NO DAMAGES OR HOLES WERE FOUND ON THE BLISTER PACKAGING AND THE DESIGN OF PACKAGING FOR SG3+2713 CAN PROVIDE ADEQUATE PROTECTION ON THE CONTENTS DURING NORMAL HANDLING AND TRANSIT. THE LOT HAS UNDERGONE 100% INSPECTION WHEREIN 2-PIECES OF PRODUCT WITH DAMAGE TO THE PACKAGE WERE FOUND. THE FOLLOWING CORRECTIVE ACTION WAS IMPLEMENTED TO ADDRESS THE SLIP THRU ON THE INSPECTION. REFRESHERS TRAINING ON THE INSPECTION PROCEDURE ((B)(4): FINISHED PRODUCT INSPECTION TREATMENT PROCEDURE AND (B)(4): SG FINISHED PRODUCT INSPECTION WORK INSTRUCTION) WAS CONDUCTED LAST AUGUST 23, 2021, TO REITERATE THE METHOD OF INSPECTION. REVISION OF THE DOCUMENT TO MAKE EMPHASIS ON THE STEP-BY-STEP PROCEDURE FOR DAMAGE TO PACKAGE INSPECTION. ADDITIONAL 1-TIME EYE REST WAS IMPLEMENTED LAST AUGUST 26, 2021, TO PREVENT EYE STRAIN. THIS COMPLAINT IS STILL FOR FURTHER INVESTIGATION. THEREFORE, A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THERE WAS A HOLE THE POUCH DURING PRODUCTION OF FD9264. THERE WAS NO 100% MVI CHECK. A SAMPLE SET OF 800 PIECES HAS BEEN FOUND WITH NO ADDITIONAL DEFECTS. THE HOLE ON THE BLISTER AFFECTING STERILITY WAS NOT VISIBLE TO THE USER, HENCE, PROBABILITY OF USING THE UNSTERILE PRODUCT IS HIGH. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1541093 TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE (SHORT SHEATH) NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO PHILIPPINES CORPORATION N/A 210313D 34806017509713

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown