BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE

    MDR report key: 12694108 · Received October 25, 2021

    Report

    Report Number
    1920898-2021-01108
    Event Type
    Malfunction
    Date Received
    October 25, 2021
    Date of Event
    September 27, 2021
    Report Date
    October 26, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K941657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-10-21. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (133) 1/2CC, 12.7MM, 29G (7 IN AN OPEN POLY BAG, 126 IN SEALED POLY BAGS) FROM LOT # 0294217. CUSTOMER STATES THAT THE NEEDLES ARE MISSING. THIRTY OUT OF 133 RETURNED SYRINGES WERE EXAMINED (7 FROM THE OPEN POLY BAG, 23 FROM THE SEALED POLY BAGS) AND ONE SAMPLE FROM THE OPEN POLY BAG EXHIBITED A MISSING CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0294217. 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. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE NEEDLE MISSING. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DISTRIBUTOR REPORTED A CARTON CONTAINING SOME BROKEN NEEDLES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 1 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE DISTRIBUTOR REPORTED A CARTON CONTAINING SOME BROKEN NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1585774 BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0294217

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown