BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD SAFETYGLIDE INSULIN SYRINGE W/ ATTACHED NEEDLE

    MDR report key: 8900901 · Received August 16, 2019

    Report

    Report Number
    1213809-2019-00836
    Event Type
    Malfunction
    Date Received
    August 16, 2019
    Date of Event
    July 30, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903059035
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER WAS UNKNOWN. THE COMPLAINT IS UNCONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT: SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE W/ ATTACHED NEEDLE HAD A SAFETY MECHANISM FAILURE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305903 BATCH NO.: UNKNOWN (REPORTED: ALL LOTS). IT WAS REPORTED THAT THE SAFETY MECHANISM IS CAUSING NEAR MISSES AND THE NEEDLE IS COMING APART FROM THE SYRINGE. CONCERN DESCRIPTION: SINCE NEW PRODUCT HAS APPEARED WE HAVE HAD 4 PSLS RE. THE NEW VITAMIN K SYRINGES (BD SAFETYGLIDE) 1 ML 25 G 5/8 LUER SLIP SYRINGE. THE NURSES WOULD LIKE TO HAVE THEM CHANGED BACK TO LUER LOCK SYRINGES. ISSUES ARE THE SAFETY MECHANISM CAUSING NEAR MISSES AND THE NEEDLE COMING APART FROM THE SYRINGE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDICAL DEVICE TYPE: FMI. ADDITIONAL COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. PMA/510(K)#: K980580 (SYRINGE), K951254 (NEEDLE). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE W/ ATTACHED NEEDLE HAD A SAFETY MECHANISM FAILURE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305903, BATCH NO.: UNKNOWN (REPORTED: ALL LOTS). IT WAS REPORTED THAT THE SAFETY MECHANISM IS CAUSING NEAR MISSES AND THE NEEDLE IS COMING APART FROM THE SYRINGE. CONCERN DESCRIPTION: SINCE NEW PRODUCT HAS APPEARED WE HAVE HAD 4 PSLS RE. THE NEW VITAMIN K SYRINGES (BD SAFETYGLIDE) 1 ML 25 G 5/8 LUER SLIP SYRINGE. THE NURSES WOULD LIKE TO HAVE THEM CHANGED BACK TO LUER LOCK SYRINGES. ISSUES ARE THE SAFETY MECHANISM CAUSING NEAR MISSES AND THE NEEDLE COMING APART FROM THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694910 1 ML BD SAFETYGLIDE INSULIN SYRINGE W/ ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903059035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other