BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 8527232 · Received April 18, 2019

    Report

    Report Number
    1920898-2019-00360
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    April 3, 2019
    Report Date
    April 24, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8171799. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED FOR PUSHROD/ADAPTER SEPARATION. THERE WERE THREE (3) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE SAFETY DEVICE IS COMING OFF OF THE SYRINGE. THIS OCCURRED ON 4 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305932 BATCH NO.: 8171799. IT WAS REPORTED THE SAFETY DEVICE IS COMING OFF THE INSULIN SYRINGE. VERBATIM: WE RECEIVED A CALL AND THEY WANTED TO REPORT AN ISSUE THEY WERE INFORMED ABOUT. THEY SAID IT¿S REGARDING ITEM 305930, THE LOT NUMBER THEY PROVIDED IS 8171799(N), THEY WERE TOLD THAT THE SAFETY DEVICE IS COMING OFF THE INSULIN SYRINGE. I COULDN¿T VERIFY THE ITEM AND LOT NUMBER IN OUR SYSTEM, THEY SAID IT HAD THE LETTER ¿N¿ AT THE END. CALLED AND SPOKE WITH CUSTOMER WHO STATES: WHEN THE SYRINGE WAS REMOVED FROM THE PACKAGE, THE ORANGE CAP AND THE SAFETY DEVICE FELL OFF.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE SAFETY DEVICE IS COMING OFF OF THE SYRINGE. THIS OCCURRED ON 4 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305932 BATCH NO.: 8171799. IT WAS REPORTED THE SAFETY DEVICE IS COMING OFF THE INSULIN SYRINGE. VERBATIM: WE RECEIVED A CALL AND THEY WANTED TO REPORT AN ISSUE THEY WERE INFORMED ABOUT. THEY SAID IT¿S REGARDING ITEM 305930, THE LOT NUMBER THEY PROVIDED IS 8171799(N), THEY WERE TOLD THAT THE SAFETY DEVICE IS COMING OFF THE INSULIN SYRINGE. I COULDN'T VERIFY THE ITEM AND LOT NUMBER IN OUR SYSTEM, THEY SAID IT HAD THE LETTER ¿N¿ AT THE END. CALLED AND SPOKE WITH CUSTOMER WHO STATES: WHEN THE SYRINGE WAS REMOVED FROM THE PACKAGE, THE ORANGE CAP AND THE SAFETY DEVICE FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318870 BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE MEG BD MEDICAL - DIABETES CARE 8171799

    Patients

    Seq Age Sex Outcome Treatment
    1 Other