BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFEASSIST¿ SAFETY PEN NEEDLE

    MDR report key: 17234734 · Received June 29, 2023

    Report

    Report Number
    9616656-2023-00678
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 9, 2023
    Report Date
    July 20, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES/PHOTOS WERE RETURNED FOR INVESTIGATION. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. THIS COMPLAINT WAS CONFIRMED TO BE A PACKAGING GRAPHICS ERROR THEREFORE A REVIEW OF THE PACKAGING PROCESS AT THE SITE IS NOT REQUIRED.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFEASSIST¿ SAFETY PEN NEEDLE HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: SKU: 329917 SAFEASSIST PRODUCT ON THE FIELD WITH INCORRECT PZN NUMBER (GERMANY) AND INCORRECT PHARMACODE (SWITZERLAND) INCORRECT CODES PZN: 15320176 PHC: 6365731 CORRECT CODES PZN SHOULD BE 15320182 PHARMACODE 6365748.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFEASSIST¿ SAFETY PEN NEEDLE HAD INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: SKU: 329917 SAFEASSIST PRODUCT ON THE FIELD WITH INCORRECT PZN NUMBER (GERMANY) AND INCORRECT PHARMACODE (SWITZERLAND) INCORRECT CODES: PZN: 15320176. PHC: 6365731. CORRECT CODES: PZN SHOULD BE 15320182. PHARMACODE 6365748.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001226 BD SAFEASSIST¿ SAFETY PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown