BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETY NEEDLE 25 G X 1"

    MDR report key: 8124495 · Received December 3, 2018

    Report

    Report Number
    1017768-2018-00528
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 3, 2018
    Report Date
    January 30, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHRS) FOR LOT NUMBERS 820844, 820100 AND 821923 INDICATES PRODUCT AND SPECIFICATION REQUIREMENTS WERE MET WITH NO NON-CONFORMING PRODUCT IDENTIFIED RELATING TO THIS CUSTOMER REPORT. A LOT CANNOT BE RELEASED UNLESS IT PASSES ALL QUALITY AND CONFORMANCE REQUIREMENTS. IN-PROCESS PROCEDURES ARE ALSO IN PLACE TO PREVENT NONCONFORMING PRODUCT IN THE MANUFACTURING PROCESS. THIS ENSURES COMPONENTS AND FINISHED PRODUCTS MEET ALL QUALITY INSPECTION STANDARDS. THESE CONTROLS INCLUDE, BUT ARE NOT LIMITED TO: MATERIAL VERIFICATION/CERTIFICATION PROCESSES, DIMENSIONAL SPECIFICATIONS, STATISTICAL SAMPLINGS, PERIODIC AUDITS, PROCESS INSPECTIONS, MACHINE MAINTENANCE/OPERATION AND PERSONNEL TRAINING AND CERTIFICATION. SPECIFICALLY, SAMPLES ARE INSPECTED FOR FOREIGN MATTER AND MOLDING FLASH. A REVIEW OF MAINTENANCE RECORDS (BOTH CORRECTIVE AND PREVENTIVE) AND CALIBRATION RECORDS SHOWED NO ISSUES RELATED TO THE REPORTED CONDITION. ALL SCHEDULED MAINTENANCE AND CALIBRATION ACTIVITIES WERE COMPLETED. THERE WAS NO PROCESS OR MATERIAL CHANGES RELATED TO THE REPORTED CONDITION. A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND REVEALED NO ISSUES. A REVIEW OF THE ENTIRE DHR FOR ALL LOT NUMBERS IDENTIFIED NO MANUFACTURING OR INSPECTION ANOMALIES. THE SHOP ORDERS FOR THE SAFETY NEEDLES ASSEMBLED FOR THIS LOT WERE ALSO REVIEWED. THERE WERE NO NCRS ISSUED AGAINST ANY OF THE SHOP ORDERS AND NO ISSUES REPORTED PERTAINING TO PRODUCT VISUAL/PHYSICAL INSPECTIONS. THERE WERE ALSO NO NCRS ISSUED AGAINST THE SHOP ORDERS OF THE MOLDED SAFETY SHIELDS UTILIZED IN PRODUCTION OF THE PRODUCT. THERE WERE EIGHT (8) PICTURES ATTACHED TO THIS COMPLAINT FILE THAT CAN BE USED TO CONFIRM THE PRESENCE OF STRING FLASH THAT ORIGINATES FROM THE GATE OF THE SAFETY SHIELD AND WRAPS AROUND THE CANNULA. THERE WERE NO PHYSICAL SAMPLES PROVIDED WITH THIS COMPLAINT AND THE PICTURES COULD NOT BE USED TO DETERMINE WHETHER THE HUBS OF THESE SAMPLES WOULD LEAK. THERE WERE NO DEFECTS OR NCRS FOR HUB LEAKAGE OR DAMAGE ISSUED AGAINST THE NEEDLES USED IN PRODUCTION OF LOT 821923. SINCE THE ALLEGED DEFECT OF HUB LEAKS COULD NOT BE CONFIRMED, BUT THE STRING FLASH DEFECT WAS CONFIRMED, IT WAS DECIDED TO LEVERAGE AN EXISTING COMPLAINT TO SATISFY THIS INVESTIGATION. THERE ARE THREE LOT NUMBERS ASSOCIATED WITH THIS COMPLAINT: 821923, 820100 AND 820844. A SUMMARY OF ALL SAMPLES RECEIVED UNDER THIS COMPLAINT IS AS FOLLOWS: THERE WERE SEVENTEEN (17) NEEDLE ASSEMBLIES AND ONE (1) EMPTY UNIT PACKAGE (OPENED) RETURNED WITH THIS COMPLAINT. THE UNIT PACKAGE WAS LABELED WITH ITEM NUMBER 8881850510, LOT 821923. THERE WAS NO OTHER LABELING PROVIDED WITH THIS COMPLAINT. ALL NEEDLES WERE VISUALLY EXAMINED AND HAD A VERY THIN PIECE OF STRING FLASH WRAPPING AROUND THE CANNULA. THE STRING FLASH ORIGINATED FROM THE GATE OF THE SAFETY SHIELD, SO IT¿S NOT FOREIGN CONTAMINATION OF THE DEVICE. THE SAFETY SHIELDS WERE EXAMINED AND WERE IMPRINTED WITH AN INDICATOR THAT TRACES TO TWELVE (12) DIFFERENT CAVITIES FROM MOLD NUMBER 823. THERE WERE THREE (3) SUBSEQUENT SAMPLES (OPENED) RECEIVED AND EVALUATED. ONE (1) SAMPLE WAS FROM LOT NUMBER 820100, A SECOND WAS FROM LOT NUMBER 821923 AND A THIRD WAS FROM AN UNKNOWN LOT NUMBER (POTENTIALLY 820844). ALL SAMPLES WERE VISUALLY EXAMINED AND HAD A VERY THIN PIECE OF STRING FLASH WRAPPING AROUND THE CANNULA. THE STRING FLASH ORIGINATED FROM THE GATE OF THE SAFETY SHIELD, SO IT¿S NOT FOREIGN CONTAMINATION OF THE DEVICE. THE SAFETY SHIELD FROM LOT 820100 WAS EXAMINED AND WAS IMPRINTED WITH AN INDICATOR THAT TRACES TO MOLD NUMBER 824. THE SAFETY SHIELD FROM LOT 821923 WAS EXAMINED AND WAS IMPRINTED WITH AN INDICATOR THAT TRACES TO MOLD NUMBER 823. THE SAFETY SHIELD FROM THE UNKNOWN LOT WAS EXAMINED AND WAS IMPRINTED WITH AN INDICATOR THAT TRACES TO MOLD NUMBER 823. THE REPORTED CONDITION WAS OBSERVED WITHIN THE SAMPLES. THE EXACT ROOT CAUSE OF THE MOLDING FLASH COULD NOT BE DETERMINED BASED ON AVAILABLE INFORMATION. THE CUSTOMER PROVIDED A PHOTO OF THE SAMPLE AND THE DEFECT OF STRING FLASH WAS IDENTIFIED UPON PHOTO REVIEW. THE MOST PROBABLE ROOT CAUSE WAS DUE TO FLASH, WHICH IS STRINGY PLASTIC MATERIAL ATTACHED AT THE MOLDED PART'S GATE (THE ENTRANCE TO THE MOLD CAVITY) FORMING WHEN MELTED PLASTIC RESIN REMAINS AT THE INJECTION GATE AS THE TWO MOLD HALVES SEPARATE. AN ISSUE IMPACT ASSESSMENT (AS KNOWN AS A HEALTH HAZARD EVALUATION OR HEALTH HAZARD ASSESSMENT) WAS CONDUCTED FOR MAGELLAN GATE STRINGS. THE BIOCOMPATIBILITY TESTING REPORT FOR THE MAGELLAN SAFETY NEEDLES REVEALED THAT THE PRODUCT DEMONSTRATED NO EVIDENCE OF CYTOTOXICITY, THE MATERIAL HAS NO EVIDENCE OF POTENTIAL SENSITIZATION, NO EVIDENCE OF HEMOLYSIS AND NO EVIDENCE OF ACUTE SYSTEMIC TOXICITY. THE BIOCOMPATIBILITY TESTING REPORT CONFIRMS THE POTENTIAL HARM IS LOW RISK. THE OVERALL RISK SCORE WAS ¿LOW¿ FOR ISSUE IMPACT ASSESSMENT. BASED ON THE LOW RISK ASSOCIATED WITH THE ISSUE, NO ADDITIONAL CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THE REPORTED CUSTOMER COMPLAINT IS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THIS ISSUE IS DUE TO FLASH. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE ARE FIBERS ON THE MAGELLAN SAFETY NEEDLES AND THAT THE HUBS ARE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965361 SAFETY NEEDLE 25 G X 1" NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 8881850510 821923

    Patients

    Seq Age Sex Outcome Treatment
    1