BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿

    MDR report key: 14744957 · Received June 20, 2022

    Report

    Report Number
    1920898-2022-00395
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 23, 2022
    Report Date
    July 15, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED TWO 0.5ML, 31 GAUGE, 8MM SYRINGES FROM LOT 1242736. THE SYRINGES HAVE HAD THEIR NEEDLE SHIELD AND HUB SEPARATE FROM THE BARREL. THE HUBS HAVE BECOME LODGED INSIDE THE SHIELDS. THERE IS NO DAMAGE TO EITHER THE CONNECTORS AT THE DISTAL TIP OF THE BARRELS OR THEIR RESPECTIVE NEEDLE HUBS. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1242736. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION. CAPA PR1630423 HAS BEEN OPENED TO ADDRESS THIS ISSUE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ THAT THE NEEDLE HUB SEPARATED INSIDE OF THE SHIELD WHEN TRYING TO REMOVE THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE HUB SEPARATED INSIDE OF THE SHIELD WHILE TRYING TO REMOVE THE SHIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ THAT THE NEEDLE HUB SEPARATED INSIDE OF THE SHIELD WHEN TRYING TO REMOVE THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE HUB SEPARATED INSIDE OF THE SHIELD WHILE TRYING TO REMOVE THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156476 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE 328468 1242736 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown