BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VEO INSULIN SYRINGES WITH BD ULTRA-FINE 6MM X 31G NEEDLE

    MDR report key: 11152612 · Received January 11, 2021

    Report

    Report Number
    1920898-2021-00018
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 14, 2020
    Report Date
    April 6, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHARMACIST

    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: 2021-03-18. INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) 3/10CC, 6MM, 31G SYRINGES IN AN OPEN POLY BAG FROM LOT # 0139079. CUSTOMER STATES THAT THERE IS A FOREIGN SUBSTANCE ON PLUNGER ROD. ALL RETURNED SYRINGES WERE EXAMINED AND NO FOREIGN MATTER WAS OBSERVED ON THE PLUNGER RODS OR ANYWHERE ELSE ON THE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 0139079 AND 0083503 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE FOREIGN MATTER WAS DISCOVERED ON PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST REPORTED COMPLAINT ON BEHALF OF CONSUMER. STATED TWO BOXES OF THE 6MM SYRINGES HAVE SOME SORT OF OIL OR SUBSTANCE ON THE PLUNGER INSIDE OF THE BARREL.STATED THE CONSUMER NOTICED THIS WHEN DRAWING BACK THE PLUNGER AND RETURNED THE BOXES TO THE STORE. PHARMACIST PROVIDED REPLACEMENTS TO CONSUMER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0083503, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-03-23. MEDICAL DEVICE LOT #: 0139079, MEDICAL DEVICE EXPIRATION DATE: 2025-05-31, DEVICE MANUFACTURE DATE: 2020-05-18. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ 6MM X 31G NEEDLE FOREIGN MATTER WAS DISCOVERED ON PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST REPORTED COMPLAINT ON BEHALF OF CONSUMER. STATED TWO BOXES OF THE 6MM SYRINGES HAVE SOME SORT OF OIL OR SUBSTANCE ON THE PLUNGER INSIDE OF THE BARREL. STATED THE CONSUMER NOTICED THIS WHEN DRAWING BACK THE PLUNGER AND RETURNED THE BOXES TO THE STORE. PHARMACIST PROVIDED REPLACEMENTS TO CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42119 BD VEO INSULIN SYRINGES WITH BD ULTRA-FINE 6MM X 31G NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1