BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVENT NEEDLE

    MDR report key: 7669723 · Received July 9, 2018

    Report

    Report Number
    1017768-2018-00049
    Event Type
    Malfunction
    Date Received
    July 9, 2018
    Report Date
    October 5, 2018
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED AT THE MANUFACTURING SITE FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    SUBMISSION DATE: 08/27/2018. AN INVESTIGATION WAS PERFORMED FOR THE REPORTED CUSTOMER COMPLAINT: ¿THE CUSTOMER REPORTED: MMR VACCINE FROM MERCK WAS DRAWN UP INTO SYRINGE. THE NEEDLE WAS CHANGED OUT FOR A NEW NEEDED AFTER VACCINE WAS IN SYRINGE. SYRINGE WAS THEN READY FOR INJECTION. WHEN VACCINE WAS BEING ADMINISTERED, THE NEEDLE AND SYRINGE SHATTERED WHEN PRESSURE WAS APPLIED TO INJECT THE VACCINATION.¿ A REVIEW OF THE DEVICE HISTORY RECORD (DHR) OF THE REPORTED LOT NUMBER 801088 INDICATES THAT PRODUCT AND SPECIFICATION REQUIREMENTS WERE MET WITH NO NON-CONFORMING PRODUCT IDENTIFIED RELATING TO THIS CUSTOMER REPORT. DURING THE MANUFACTURING OF THE SYRINGE ASSEMBLIES, SYRINGES WERE VISUALLY INSPECTED AND PHYSICALLY TESTED. NO DEFICIENCIES WERE RECORDED RELATING TO THIS CUSTOMER REPORT. CONTROL MECHANISMS ARE IN PLACE TO PREVENT THE OCCURRENCE AND ACCEPTANCE OF DAMAGED SYRINGES OR SYRINGES WHICH LEAK DURING THE SYRINGE MOLDING, ASSEMBLY AND PACKAGING PROCESSES. THESE INCLUDE, BUT ARE NOT LIMITED TO: MATERIAL VERIFICATION/CERTIFICATION PROCESSES, DIMENSIONAL SPECIFICATIONS, MACHINE MAINTENANCE REQUIREMENTS, AND PERSONNEL TRAINING AND CERTIFICATION. A LOT CANNOT BE RELEASED UNLESS IT PASSES ALL VISUAL AND PHYSICAL TESTING REQUIREMENTS. MAINTENANCE RECORDS (CORRECTIVE AND PREVENTIVE), CALIBRATION RECORDS, PROCESS MONITORING DATA AND MACHINE SET UP WERE ALL REVIEWED WITH NO ISSUES RELATED TO THE REPORTED CONDITION. THERE WERE NO CHANGES TO THE PROCESS OR MATERIALS RELATED TO THE REPORTED EVENT FOR THIS PRODUCT. EQUIPMENT WAS REVIEWED FOR MALFUNCTIONS OR ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, BUT NO SUCH ISSUES WERE OBSERVED DURING THE REVIEW. ONE (1) UNOPENED SAMPLE AND ONE (1) EMPTY PACKAGE WERE RECEIVED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED AND THERE WERE NO SIGNS OF DAMAGE FOUND ON THE NEEDLE. THE SAMPLE WAS ATTACHED TO A SYRINGE THAT WAS RETURNED AS PART OF ANOTHER INVESTIGATION FOR THIS CUSTOMER. THE SAMPLE WAS TESTED FOR LUER LEAKAGE AND OCCLUDED CANNULA WITH NO ISSUES IDENTIFIED DURING TESTING OF THE PRODUCT. THE INVESTIGATION DID NOT IDENTIFY A SYSTEMIC ISSUE WITH THE PRODUCT OR MANUFACTURING PROCESS. A 6M ROOT CAUSE INVESTIGATION WAS CONDUCTED FOR POTENTIAL CONTRIBUTING FACTORS. THE 6M ROOT CAUSE ANALYSIS DID NOT IDENTIFY ANY ISSUES WITH THE MANUFACTURING PROCESS FOR THE NEEDLES. THERE WAS ONE POTENTIAL ROOT CAUSE IDENTIFIED DURING THE INVESTIGATION PERTAINING TO THE USER¿S APPLICATION OF THE DEVICE. HOWEVER, THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHETHER THIS FACTOR WAS THE DEFINITIVE ROOT CAUSE. IT¿S RECOMMENDED FOR THE USER TO CONSULT THE INSTRUCTIONS FOR USE (IFU) WHEN UTILIZING THE DEVICE. THE REPORTED CUSTOMER COMPLAINT IS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE UTILIZED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: MMR VACCINE FROM MERCK WAS DRAWN UP INTO SYRINGE. THE NEEDLE WAS CHANGED OUT FOR A NEW NEEDED AFTER VACCINE WAS IN SYRINGE. SYRINGE WAS THEN READY FOR INJECTION. WHEN VACCINE WAS BEING ADMINISTERED, THE NEEDLE AND SYRINGE SHATTERED WHEN PRESSURE WAS APPLIED TO INJECT THE VACCINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514052 PREVENT NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 26558 801088

    Patients

    Seq Age Sex Outcome Treatment
    1