BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 10557373 · Received September 18, 2020

    Report

    Report Number
    1920898-2020-01263
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 28, 2020
    Report Date
    October 20, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 19 OCTOBER 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0132200 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200894508, 200893682] NOTED FOR OUT OF SPEC SHIELD PULLS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED NEEDLE HUB SEPARATION. THIS OCCURRED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED ORANGE CAP WITH TIP IS BREAKING WHEN PULLED APART AND BREAKS AWAY FROM THE SYRINGE VERBATIM: MFR ITEM # 328438 MMS ITEM # 1030268 PRODUCT NAME SYRINGE/NDL, INSULIN 3/10CC 31GX5/16" (10/BG 10BG/BX 5BX/CS) LOT / SERIAL NUMBER (B)(6) PRODUCT CONCERN: ORANGE CAP WITH TIP IS BREAKING WHEN PULLED APART AND BREAKS AWAY FROM THE SYRINGE BECTON DICKINSON: PLEASE NOTE THAT MCKESSON MEDICAL-SURGICAL RECEIVED THE COMPLAINT BELOW WHICH INVOLVES A NATIONAL BRANDED PRODUCT. THIS COMMUNICATION IS INTENDED FOR YOUR QUALITY ASSURANCE DEPARTMENT. FOR TRACEABILITY PURPOSES, THE COMPLAINT WAS ASSIGNED A MCKESSON INTERNAL NUMBER NAT-(B)(4). THIS INTERNAL NUMBER IS A POINT OF REFERENCE TO ENSURE COMPLAINTS ARE PROPERLY ROUTED TO NATIONAL BRAND SUPPLIERS. IT IS YOUR RESPONSIBILITY AS THE SUPPLIER, TO OBTAIN ANY ADDITIONAL INFORMATION THAT MAY BE NECESSARY TO CONDUCT A THOROUGH INVESTIGATION."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED NEEDLE HUB SEPARATION. THIS OCCURRED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED ORANGE CAP WITH TIP IS BREAKING WHEN PULLED APART AND BREAKS AWAY FROM THE SYRINGE. VERBATIM: MFR ITEM # 328438. MMS ITEM # 1030268. PRODUCT NAME: SYRINGE/NDL, INSULIN 3/10CC 31GX5/16" (10/BG 10BG/BX 5BX/CS). LOT / SERIAL NUMBER: (B)(4). PRODUCT CONCERN: ORANGE CAP WITH TIP IS BREAKING WHEN PULLED APART AND BREAKS AWAY FROM THE SYRINGE. BECTON DICKINSON PLEASE NOTE THAT MCKESSON MEDICAL-SURGICAL RECEIVED THE COMPLAINT BELOW WHICH INVOLVES A NATIONAL BRANDED PRODUCT. THIS COMMUNICATION IS INTENDED FOR YOUR QUALITY ASSURANCE DEPARTMENT. FOR TRACEABILITY PURPOSES, THE COMPLAINT WAS ASSIGNED A MCKESSON INTERNAL NUMBER (B)(4). THIS INTERNAL NUMBER IS A POINT OF REFERENCE TO ENSURE COMPLAINTS ARE PROPERLY ROUTED TO NATIONAL BRAND SUPPLIERS. IT IS YOUR RESPONSIBILITY AS THE SUPPLIER, TO OBTAIN ANY ADDITIONAL INFORMATION THAT MAY BE NECESSARY TO CONDUCT A THOROUGH INVESTIGATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022016 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 0132200 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other