BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 10048281 · Received May 12, 2020

    Report

    Report Number
    1920898-2020-00504
    Event Type
    Malfunction
    Date Received
    May 12, 2020
    Date of Event
    April 21, 2020
    Report Date
    June 2, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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: 5/13/2020. H.6. INVESTIGATION: CUSTOMER RETURNED NINE (9) 31GX6MM, 0.3ML BD INSULIN SYRINGES IN AN OPEN POLYBAG FROM LOT 9252570. CONSUMER REPORTED USING ITEM 324910 LOT # 7233893, AND FEELS A BAG OF 324909 WITH LOT # 9252570 WAS WITHIN THIS BOX (MIXED PRODUCT WITHIN BOX). THE RETURNED SAMPLES WERE EXAMINED, HOWEVER, NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE THE SAMPLES WERE RETURNED OUT OF THE ORIGINAL SHELF CARTON IT COULD NOT BE DETERMINED IF THIS POLYBAG WAS INCORRECTLY PACKAGED TOGETHER DURING THE MANUFACTURING PROCESS. FURTHERMORE, THESE LOTS (LOT 7233893 AND LOT 9252570) WERE MANUFACTURED OVER A YEAR APART, SO IT IS UNLIKELY THAT THESE PRODUCTS WOULD BE PACKAGED TOGETHER AS A RESULT OF A MANUFACTURING DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7233893. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HAD A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FELT THERE WAS A MIX OF PRODUCT WITH THE BOX OF PRODUCT. ONE PACKET OF 10 HAD A DIFFERENT ITEM NUMBER AND LOT NUMBER THAN WHAT THE BOX STATED.

    Additional Manufacturer Narrative · 1

    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 DURING USE THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE HAD A MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER FELT THERE WAS A MIX OF PRODUCT WITH THE BOX OF PRODUCT. ONE PACKET OF 10 HAD A DIFFERENT ITEM NUMBER AND LOT NUMBER THAN WHAT THE BOX STATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509982 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 7233893 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other