BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 0.5ML 31GA 6MM

    MDR report key: 12269369 · Received August 3, 2021

    Report

    Report Number
    1920898-2021-00850
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 7, 2021
    Report Date
    August 5, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: (B)(6)2021. H.6. INVESTIGATION: CUSTOMER RETURNED (13) LOOSE 0.5ML BD INSULIN SYRINGES. CONSUMER REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE SYRINGE AND WAS STUCK INSIDE OF THE SHIELD. ALL 13 RETURNED SYRINGES WERE EXAMINED, AND IT WAS OBSERVED THAT 10 OF THE SYRINGES EXHIBITED A NEEDLE HUB/SHIELD ASSEMBLY DETACHED FROM THE BARREL. NO DAMAGE TO THE BARREL TIPS WAS OBSERVED (SEE ATTACHED PHOTOS). THE REMAINING 3 SYRINGES DID NOT EXHIBIT DETACHED HUB ASSEMBLIES; REMOVING THE CANNULA SHIELDS FROM THESE 3 SYRINGES DID NOT RESULT IN HUB SEPARATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0139024. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1053427. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0006789. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. CAPA#1630423 WAS INITIATED. ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD SYRINGE 0.5ML 31GA 6MM HUBS SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE SYRINGE AND WAS STUCK INSIDE OF THE SHIELD. DATE OF EVENT : UNKNOWN. SAMPLES: AVAILABLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: LOT #: 0139024 ¿ DEVICE EXPIRATION DATE: 05/31/2025 ¿ DEVICE MANUFACTURE DATE: 05/18/2020. LOT #: 1053427 ¿ DEVICE EXPIRATION DATE: 03/31/2026, DEVICE MANUFACTURE DATE: 02/22/2021. LOT #: 0006789 ¿ DEVICE EXPIRATION DATE: 01/31/2025 ¿ DEVICE MANUFACTURE DATE: 01/06/2020. 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 3 BD SYRINGE 0.5 ML 31 GA 6 MM HUBS SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE SYRINGE AND WAS STUCK INSIDE OF THE SHIELD. DATE OF EVENT: UNKNOWN, SAMPLES: AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163858 BD SYRINGE 0.5ML 31GA 6MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1