BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 10075833 · Received May 20, 2020

    Report

    Report Number
    1213809-2020-00326
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    April 28, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059011
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FOUR PHOTOS WERE RECEIVED AND EVALUATED. TWO PHOTOS APPEARED TO DISPLAY THE TOP VIEW OF THE SAME SAFETYGLIDE BLISTER PACK FROM BATCH 8241616 (P/N 305901). TWO PHOTOS DISPLAYED A CANNULA WITH A STRAND OF WHITE OR CLEAR FOREIGN MATTER WRAPPED AROUND THE TIP. THE FOREIGN MATTER WAS OUTSIDE THE FLUID PATH AND APPEARED TO BE PLASTIC AND LARGER THAN LEVEL 3 IN SIZE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. A POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE NEEDLE MANUFACTURING PROCESS. THE PHOTOS WERE FORWARDED TO THE NEEDLE MANUFACTURING SITE FOR EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. THE NEEDLE MANUFACTURER (BD COLUMBUS) WAS ABLE TO REVIEW THE PHOTOS BUT WAS UNABLE TO PROVIDE AN ACCURATE ROOT CAUSE WITHOUT THE AFFECTED SAMPLE AVAILABLE. DHR WAS PERFORMED. THERE WAS NO DOCUMENTATION FOR THIS TYPE OF DEFECTS DURING THE ENTIRE PRODUCTION RUN OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER CONTAMINATION AND SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305901 BATCH NO.: 8241616. CN STATED WHEN THE NEEDLE WAS INSERTED ON THE HUB OF A SYRINGE TO BE PRIMED, SHARDS OF METAL WAS COMING OFF THE NEEDLE, THE SAFETY COMPONENT COULD NOT BE ACTIVATED AFTER USE. REF: 305901 LOT NO. 8241616, SAMPLE WAS USED IN A NUCLEAR RADIATION ENVIRONMENT AND CANNOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    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 THE BD SAFETYGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER CONTAMINATION AND SAFETY MECHANISM FAILURE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305901 BATCH NO.: 8241616. CN STATED WHEN THE NEEDLE WAS INSERTED ON THE HUB OF A SYRINGE TO BE PRIMED, SHARDS OF METAL WAS COMING OFF THE NEEDLE, THE SAFETY COMPONENT COULD NOT BE ACTIVATED AFTER USE. REF: 305901 LOT NO. 8241616, SAMPLE WAS USED IN A NUCLEAR RADIATION ENVIRONMENT AND CANNOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537463 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305901 8241616 30382903059011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other