BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SYRINGE

    MDR report key: 11289291 · Received February 5, 2021

    Report

    Report Number
    2243072-2021-00239
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 14, 2021
    Report Date
    March 9, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. (SANDY) G.1. MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. (SANDY) H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DUE TO THE BATCH BEING UNKNOWN, NO DHR REVIEW CAN BE COMPLETED. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 11 BOXES OF AN UNSPECIFIED SYRINGE HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER HAD 11 BOXES WITHOUT THE EXPIRATION DATE. VERBATIM: RELATIVE OF CONSUMER REPORTED HAVING 11 BOXES OF INSULIN SYRINGES THAT HE FEELS ARE ABOUT 6-7 YEARS OLD.THE BOXES WERE NOT OPENED AND HE INQUIRED IF HE CAN STILL USE THE PRODUCT.NO EXPIRATION DATE OR TRADEMARK DATE ON BOXES. STATED ALL BOXES ARE THE SAME DESCRIPTION, 1/2 CC, 8MM, 31G BD INSULIN SYRINGE.ADVISED RELATIVE THAT THESE BOXES COULD ALL BE EXPIRED.FURTHER ADVISED THAT BD TESTS THE PRODUCTS FOR 5 YEARS AND CAN'T GUARANTEE THE FUNCTION OR STERILITY OF THE NEEDLE AFTER THAT TIME.CONTROL # 6143942 - SAME FOR ALL BOXESDATE OF EVENT: UNKNOWNSAMPLES: NO".

    Additional Manufacturer Narrative · 1

    "UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4)."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 11 BOXES OF AN UNSPECIFIED SYRINGE HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER HAD 11 BOXES WITHOUT THE EXPIRATION DATE. VERBATIM: RELATIVE OF CONSUMER REPORTED HAVING 11 BOXES OF INSULIN SYRINGES THAT HE FEELS ARE ABOUT 6-7 YEARS OLD. THE BOXES WERE NOT OPENED AND HE INQUIRED IF HE CAN STILL USE THE PRODUCT. NO EXPIRATION DATE OR TRADEMARK DATE ON BOXES. STATED ALL BOXES ARE THE SAME DESCRIPTION, 1/2 CC, 8MM, 31G BD INSULIN SYRINGE. ADVISED RELATIVE THAT THESE BOXES COULD ALL BE EXPIRED. FURTHER ADVISED THAT BD TESTS THE PRODUCTS FOR 5 YEARS AND CAN'T GUARANTEE THE FUNCTION OR STERILITY OF THE NEEDLE AFTER THAT TIME. CONTROL # (B)(4) - SAME FOR ALL BOXES DATE OF EVENT: UNKNOWN SAMPLES: NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185158 UNSPECIFIED BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1