BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 7434833 · Received April 16, 2018

    Report

    Report Number
    1920898-2018-00213
    Event Type
    Malfunction
    Date Received
    April 16, 2018
    Date of Event
    March 21, 2018
    Report Date
    May 9, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION: UPDATED PRODUCT AND LOT INFORMATION WAS RECEIVED THE CUSTOMER. THE FOLLOWING FIELDS HAVE BEEN UPDATED: MEDICAL DEVICE CATALOG #: 305930. MEDICAL DEVICE LOT #: 7228550. EXPIRATION DATE: 08/31/2022. UNIQUE IDENTIFIER (UDI) #: (B)(4). 510K #: K992734. DEVICE MANUFACTURE DATE: 08/16/2017. INVESTIGATION RESULTS: SUMMARY: INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) 1ML, 13MM, 29G BD SAFETYGLIDE INSULIN SYRINGES IN SEALED BLISTER PACKS FROM LOT # 7228550. CUSTOMER STATES THAT THE NURSE WENT TO PULL CAP OF SG INSULIN SYRINGE AND THE ENTIRE SAFETY ARM PULLED OFF EXPOSING THE NEEDLE ONLY. ALL RETURNED SYRINGES WERE TESTED AND THE SAFETY MECHANISM DID NOT SEPARATE FROM THE SYRINGE WHEN REMOVING THE SHIELD ON ANY OF THE SAMPLES. ALL SAMPLES WERE ALSO TESTED AND THE SAFETY MECHANISM WAS ABLE TO ACTIVATE PROPERLY ON ALL SAMPLES WITHOUT ANY OBSERVED DEFECTS. CUSTOMER ALSO RETURNED A PHOTO OF A LOOSE SAFETYGLIDE INSULIN SYRINGE. THE PHOTO WAS EXAMINED AND EXHIBITED THE SAFETY MECHANISM SEPARATED FROM THE BARREL OF THE SYRINGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7228550. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200719257] NOTED FOR SAFETY FEATURE LOOSE. THERE WAS ONE (1) NOTIFICATION [200713267] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME ROOT CAUSE: SAFETY MECHANISM SEPARATES FROM THE BARREL DURING THE SHIELDING PROCESS.

    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 NEEDLE ON A BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE SEPARATED WHEN THE NURSE "WENT TO PULL THE CAP OFF, THE ENTIRE SAFETY ARM PULLED OFF EXPOSING THE NEEDLE." THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278008 BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE SAFETY ENGINEERED SYRINGE WITH NEEDLE MEG BD MEDICAL - DIABETES CARE 7228550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other