BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 21X1-1/2 RB TW

    MDR report key: 9537294 · Received January 2, 2020

    Report

    Report Number
    1213809-2019-01320
    Event Type
    Malfunction
    Date Received
    January 2, 2020
    Date of Event
    December 12, 2019
    Report Date
    January 17, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059172
    PMA / PMN Number
    K951254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE PHOTOS AND ONE SAFETYGLIDE NEEDLE ASSEMBLY IN AN OPENED BLISTER PACK FROM BATCH 9023789 (P/N 305917) WAS RECEIVED AND EVALUATED. FROM THE PHOTOS, IT WAS OBSERVED THERE WAS A TOTAL OF SEVEN PACKAGES CONTAINING SMALL BLACK FOREIGN MATTER PARTICLES RANGING FROM LEVEL ONE TO GREATER THAN LEVEL THREE IN SIZE. THE PACKAGES HAD THE HIGHEST CONCENTRATION OF PARTICLES IN THE HUB AREA AND WERE ALSO SPREAD THROUGHOUT THE PACKAGING INCLUDING THE SEAL. TWO OF THE PACKAGES APPEARED TO HAVE SOME PARTICLES PRESENT INSIDE THE NEEDLE SHIELD WITH ONE CONTAINING PARTICLES IN THE FLUID PATH. EACH PACKAGE CONTAINED AT LEAST ONE PARTICLE LARGER THAN LEVEL 3 IN SIZE AND WERE REJECTABLE PER PRODUCT SPECIFICATION. ONE CONTAINED FOREIGN MATTER IN THE FLUID PATH LARGER THAN LEVEL 2 IN SIZE AND WAS REJECTABLE PER PRODUCT SPECIFICATION. THE PHYSICAL SAMPLE APPEARED TO BE THE NEEDLE ASSEMBLY IN THE MIDDLE OF THE SEVEN BLISTER PACKS IN THE PHOTO. THE PHYSICAL SAMPLE WAS SENT OUT FOR FOURIER TRANSFORM INFRARED SPECTROSCOPY TO CONFIRM THE COMPOSITION OF THE OBSERVED FOREIGN MATTER. THE RESULTS INDICATE IT WAS MOST LIKELY DRIED INK PARTICLES FROM THE TOP WEB PRINTER. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. THE MACHINE WAS STOPPED, AND AN ADJUSTMENT WAS MADE THAT LIKELY CAUSED THE DRIED PARTICLES FROM THE PRINTER TO FALL INTO THE BLISTER PACKS AND WERE INADVERTENTLY LOADED INTO THE BOXES. DHR WAS PERFORMED, ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 9023789 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE SFTYGLD 21X1-1/2 RB TW EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING CO-PACKING SAFETY GLIDE CANNULAS OF SUPPLIER LOT 0923789 WITH PRODUCT LOT, THE OPERATORS OBSERVED SEVEN CANNULAS WITH A STRONG DARK PARTICLE CONTAMINATION INSIDE THE BLISTER. THESE PARTICLES WERE ALSO DIRECTLY ATTACHED TO THE METAL CANNULA. THE CONTAMINATION IS LOCATED ON THE SURFACE OF THE METAL CANNULA AND THE UNKNOWN FOREIGN PARTICLES WOULD DEFINITELY COME INTO CONTACT WITH THE PATIENT. FURTHERMORE THE PATIENT WILL NOT HAVE THE POSSIBILITY TO ADMINISTER THE LIVE SAVING DRUG AND CHOOSE ANOTHER CANNULA, IF THE ONLY CO-PACKED DEVICE IS VISUALLY CONTAMINATED WITH UNKNOWN PARTICLES. DISTRIBUTOR CLASSIFIES THIS FINDING AS CRITICAL, BECAUSE THIS KIND OF PARTICLE WAS NEVER OBSERVED BEFORE AND DOES NOT SEEM TO BE INTRINSIC OR TYPICAL FOR THIS KIND OF MEDICAL DEVICE. THEREFORE, THE COMPLETE DELIVERY OF SUPPLIER LOT 9023789 WAS REJECTED. IN CONSEQUENCE LOT 9023789 (157.500 PIECES) WAS BLOCKED AND 3 ALREADY PROCESSED LOTS NEEDED TO BE REPACKED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE SFTYGLD 21X1-1/2 RB TW EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING CO-PACKING SAFETY GLIDE CANNULAS OF SUPPLIER LOT 0923789 WITH PRODUCT LOT, THE OPERATORS OBSERVED SEVEN CANNULAS WITH A STRONG DARK PARTICLE CONTAMINATION INSIDE THE BLISTER. THESE PARTICLES WERE ALSO DIRECTLY ATTACHED TO THE METAL CANNULA. THE CONTAMINATION IS LOCATED ON THE SURFACE OF THE METAL CANNULA AND THE UNKNOWN FOREIGN PARTICLES WOULD DEFINITELY COME INTO CONTACT WITH THE PATIENT. FURTHERMORE THE PATIENT WILL NOT HAVE THE POSSIBILITY TO ADMINISTER THE LIVE SAVING DRUG AND CHOOSE ANOTHER CANNULA, IF THE ONLY CO-PACKED DEVICE IS VISUALLY CONTAMINATED WITH UNKNOWN PARTICLES. DISTRIBUTOR CLASSIFIES THIS FINDING AS CRITICAL, BECAUSE THIS KIND OF PARTICLE WAS NEVER OBSERVED BEFORE AND DOES NOT SEEM TO BE INTRINSIC OR TYPICAL FOR THIS KIND OF MEDICAL DEVICE. THEREFORE, THE COMPLETE DELIVERY OF SUPPLIER LOT 9023789 WAS REJECTED. IN CONSEQUENCE LOT 9023789 (157.500 PIECES) WAS BLOCKED AND 3 ALREADY PROCESSED LOTS NEEDED TO BE REPACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4932 NEEDLE SFTYGLD 21X1-1/2 RB TW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305917 9023789 30382903059172

    Patients

    Seq Age Sex Outcome Treatment
    1 Other