BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PET SYRINGES VETERINARY INSULIN SYRINGE

    MDR report key: 14116374 · Received April 14, 2022

    Report

    Report Number
    1920898-2022-00235
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 24, 2022
    Report Date
    May 18, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903230006
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 25-APR-2022. H.6. INVESTIGATION: CUSTOMER RETURNED A SINGLE 0.3ML, 29 GAUGE, 12.7MM SYRINGE FROM LOT 1253642. THE SYRINGE HAD ITS NEEDLE SHIELD AND HUB SEPARATE FROM THE BARREL. THE HUB HAS BECOME LODGED INSIDE THE SHIELD. THERE IS NO DAMAGE TO EITHER THE CONNECTOR AT THE DISTAL TIP OF THE BARREL OR ITS RESPECTIVE NEEDLE HUB. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1253642. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PET SYRINGES VETERINARY INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED THAT THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PET SYRINGES VETERINARY INSULIN SYRINGE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PET OWNER REPORTED THAT THE NEEDLE HUB SEPARATED AND STAYED INSIDE OF THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140465 BD PET SYRINGES VETERINARY INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 323000 1253642 00382903230006

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown