BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGUARD3 SAFETY HYPODERMIC NEEDLE

    MDR report key: 20866696 · Received December 6, 2024

    Report

    Report Number
    3003902955-2024-00094
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Report Date
    December 6, 2024
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT: REQUESTED, UNKNOWN . D4: CATALOG #: POTENTIAL CODES: 1) SG3+2325, 2) SG3+2325, 3) SG3+2238 & 4) SG3+2051. D4: LOT #: POTENTIAL CODES: 1) 230327D, 2) 230625D, 3) 230619C, & 4) 230718C. D4: EXPIRATION DATE: POTENTIAL DATES: 1) 29-FEB-2028, 2) 31-MAY-2028, 3) 31-MAY-2028 & 4) 30-JUN-2028. D4: UDI: POTENTIAL #'S: (B)(4). D6A: IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. D6B: EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. E3: OCCUPATION: PRODUCT COMPLAINTS - (B)(6). G4: 510K: POTENTIAL NO.: K122249 (SG3+2325), K113422 (SG3+2238 AND SG3+2051). H4: DEVICE MANUFACTURE DATE: POTENTIAL DATES: 1) 27 MAR 2023, 2) 25 JUN 2023, 3) 19 JUN 2023, & 4) 18 JUL 2023. THE DETAILS OF THE ACTUAL CONDITION OF THE SAMPLE WERE UNABLE TO BE DETERMINED AS IT WAS NOT AVAILABLE FOR EVALUATION. RETENTION SAMPLES WERE VISUALLY INSPECTED AND CONFIRMED FREE OF DEFECTS SUCH AS DENTS, SCRATCHES, BENT CANNULA, TILTED CANNULA, AND DAMAGE TO THE CANNULA THAT MIGHT CONTRIBUTE TO THE COMPLAINT. THERE WAS NO ISSUED NONCONFORMITY REPORT RELATED TO HUMAN ERROR DURING THE PRODUCTION LOT. THE NEEDLES WERE MANUFACTURED AT NEEDLE ASSEMBLY MACHINE 1 AND 8. MACHINE 8 HAS AN INSPECTION SYSTEM THAT DETECTS TILTED AND BENT CANNULAS. DUMMY CHECKING IS CONDUCTED EVERY TYPE OF CHANGE, END OF THE LOT, MACHINE ADJUSTMENT/ TROUBLESHOOTING/ REPLACEMENT OF PARTS TO ENSURE THE ACCURACY OF THE INSPECTION SYSTEM. DURING THE COLLAR ASSEMBLY PROCESS, THE HUB FIT IS LOOSENED FROM THE PROTECTOR BEFORE PLACING THE NEEDLE INTO THE COLLAR. PRIOR TO PROCEEDING TO THE NEXT PROCESS, THE HUB, CANNULA, AND COLLAR ARE PRESSED INTO THE PROTECTOR WHEREIN A PHOTOELECTRIC SENSOR DETECTS IF THE HEIGHT OF THE PROTECTOR IS CORRECT. DURING THE CANNULA INSPECTION, THE SUPPLIED CANNULA RAW MATERIAL WHICH IS IDENTIFIED WITH THE SUFFIX "P" HAS UNDERGONE OVERALL INSPECTION. DEFECTIVE SAMPLES FOUND WILL BE SEGREGATED AND DISCARDED ACCORDINGLY. IF ANY UNUSUAL CANNULA CONDITION WAS FOUND, A NONCONFORMITY REPORT SHALL BE ISSUED. NO NONCONFORMITY REPORT WAS NOTED ON THE INVOLVED CANNULA LOT. AT THE CANNULA STATION, AN INSPECTOR ENSURES PROPER CANNULA ALIGNMENT TO PREVENT BENT NEEDLES. OUR PRODUCT HAS AN ALLOWABLE TILTING OF THE NEEDLE OF NOT MORE THAN 2°. TILTED CANNULAS ARE ONE OF THE CHECK ITEMS IN THE HOURLY IN-PROCESS INSPECTION DURING NEEDLE ASSEMBLY. VISUAL IN-PROCESS INSPECTIONS ARE CONDUCTED DURING THE MANUFACTURING PROCESS TO DETECT ABNORMALITIES IN THE PRODUCT THAT MAY CAUSE NEEDLE BREAK. BEFORE SHIPMENT, QC CONDUCTS OUTGOING INSPECTIONS TO CHECK THE OVERALL CONDITION OF THE PRODUCTS. OUR CANNULA IS A SUPPLIED RAW MATERIAL THAT COMPLIES WITH ISO 9626, PARTICULARLY ON STIFFNESS AND BREAKAGE. IT HAS UNDERGONE INCOMING INSPECTION WHICH INCLUDES VISUAL INSPECTION, DIMENSIONAL INSPECTION, AND VERIFICATION OF QUALITY CERTIFICATE. THE SUPPLIED CANNULA RAW MATERIAL IS TPC INSPECTED WHEREIN THE OVERALL VISUAL CONDITION OF THE CANNULA HAS BEEN CHECKED. FROM THE PREVIOUS TWO FISCAL YEARS TO THE PRESENT, WE RECEIVED A TOTAL OF (B)(4) COMPLAINTS FOR THE SAME ISSUE, THE CAUSE OF WHICH WAS NOT IDENTIFIED AS BEING RELATED TO OUR PRODUCT OR THE MANUFACTURING PROCESS. THE ROOT CAUSE OF THE PROBLEM COULD NOT BE IDENTIFIED BASED ON OUR INVESTIGATION OF ALL THE AVAILABLE INFORMATION REGARDING THIS ISSUE. A REVIEW OF THE PRODUCT'S LOT HISTORY FILE REVEALED NO RELATED ISSUES THAT WOULD CAUSE THE NEEDLE TO BREAK DURING INJECTION. OUR CANNULA IS SUPPLIED WITH RAW MATERIAL THAT CONFORMS TO ISO 9626, SPECIFICALLY ON STIFFNESS AND BREAKAGE. WE HAVE ROUTINE INSPECTIONS TO CHECK THE CONDITION OF THE PRODUCTS. WE PERFORM AN OUTGOING INSPECTION PRIOR TO SHIPMENT TO ENSURE THE OVERALL CONDITION OF THE NEEDLES. OUR PROCESS IS ASSURED, AND THE COMPLAINT IS UNRELATED TO OUR MANUFACTURING PROCESS. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (PHILIPPINES) CORPORATION (MANUFACTURER) REGISTRATION NO. 3003902955.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED AN ISSUE WITH AN ABILIFY MAINTENA INJECTION. DURING ADMINISTRATION, THE NEEDLE BROKE, PREVENTING THE NURSE PRACTITIONER (NP) FROM DELIVERING THE FULL DOSE. APPROXIMATELY A QUARTER OF THE MEDICATION WAS LOST. IT WAS CONFIRMED THAT THE NP DID NOT HAVE ANY EXPOSURE TO THE MEDICATION. THE DOSAGE STRENGTH WAS 400MG. ADDITIONAL INFORMATION WAS RECEIVED ON 2024 NOV 2024: IT WAS REPORTED THAT THE PATIENT RECEIVED TWO-THIRDS OF THE MEDICATION AND WILL RECEIVE THEIR NEXT DOSE SLIGHTLY EARLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2488826 SURGUARD3 SAFETY HYPODERMIC NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO PHILIPPINES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABILIFY MAINTENA DOSAGE STRENGTH 400MG