BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAFETYGLIDE¿ INSULIN SYRINGE, THIN WALL; 30GX8MM

    MDR report key: 5895010 · Received August 22, 2016

    Report

    Report Number
    1920898-2016-00022
    Event Type
    Injury
    Date Received
    August 22, 2016
    Date of Event
    July 26, 2016
    Report Date
    August 23, 2016
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K992734
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THREE SAMPLES FROM THE REPORTED CATALOG 305934. TWO SAMPLES WERE RETURNED SEALED AND ONE SAMPLE WAS RETURNED LOOSE WITHOUT PACKAGING FROM AN UNKNOWN LOT. THE RETURNED SEALED SAMPLES CAME FROM TWO DIFFERENT LOTS; ONE SAMPLE FROM LOT 6050959 AND ONE FROM LOT 6081895. THE TWO SEALED SYRINGES WERE VISUALLY INSPECTED AND NO DEFECTS OR ISSUES WERE OBSERVED. THEY WERE ACTIVATED WITHOUT AN ISSUE AND THEIR SAFETY MECHANISM DID NOT BREAK OFF. THE ONE LOOSE SAMPLE WAS RETURNED WITHOUT THE SAFETY MECHANISM. THIS IS EVIDENCE THAT THE SAFETY MECHANISM BROKE, WHICH COULD HAVE LED TO THE REPORTED NEEDLE STICK INJURY. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE POTENTIAL REPORTED LOT NUMBERS. LOT 6050959 WAS PACKAGED FROM 5/12/2016 TO 5/16/2016 AND LOT 6081895 WAS PACKAGED FROM 4/26/2016 TO 4/28/2016. ALTHOUGH THERE WERE ZERO (0) DEFECTS OR NOTIFICATIONS NOTED FOR ANY HUB DISENGAGEMENT, THERE WERE SEVEN (7) HUB RELATED QUALITY NOTIFICATIONS NOTED DURING THE PRODUCTION OF THESE BATCHES. FOR LOT 6050959 THE FOLLOWING THREE (3) QN'S WERE NOTED: BROKEN CORE PIN, INCOMPLETES IN MOLD, AND BROKEN CORE PIN IN CAVITY. FOR LOT 6081895 THE FOLLOWING FOUR (4) QN'S WERE NOTED: BROKEN CORE PIN IN CAVITY, INCOMPLETES IN CAVITY, PULLED CORK IN CAVITY, AND CRACKED HUBS ON ASSEMBLY. BASED ON THE USED SAMPLE RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT WAS NOT DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DEVICE USED IN THIS INCIDENT WAS DISCARDED. THE EXACT LOT NUMBER USED IN THIS INCIDENT IS UNKNOWN BUT TWO POTENTIAL LOT NUMBERS WERE PROVIDED: THE LOT 6050959- MEDICAL DEVICE EXPIRATION DATE (B)(6) 2021, DEVICE MANUFACTURE DATE (B)(6) 2016. THE LOT 6081895- MEDICAL DEVICE EXPIRATION DATE (B)(6) 2021, DEVICE MANUFACTURE DATE (B)(6) 2016. DEVICE EVALUATION: SAMPLES HAVE BEEN RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING USE, THE EMPLOYEE WAS PUSHING UP THE SAFETY SHIELD OF THE SUSPECT DEVICE WHEN THE SHIELD FELL OFF, RESULTING IN A NEEDLE STICK INJURY. THE EMPLOYEE WAS EXAMINED AND LAB WORK WAS PERFORMED. AT THE TIME OF REPORT, THE RESULTS WERE PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545328 BD SAFETYGLIDE¿ INSULIN SYRINGE, THIN WALL; 30GX8MM INSULIN SYRINGE AND NEEDLE FMF BD MEDICAL - DIABETES CARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention