BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE¿ 3 NEEDLES

    MDR report key: 16527181 · Received March 10, 2023

    Report

    Report Number
    3002682307-2023-00050
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    February 14, 2023
    Report Date
    May 15, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    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: 28-APR-2023. H6: INVESTIGATION SUMMARY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300700 AND LOT NUMBER 220327. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, A CASE CARTON OF PRODUCT WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THE CASE CARTON WAS NOT A BD PRODUCED CASE CARTON, IT WAS FROM MÖNLYCKE. WITHIN THE CASE CARTON, (B)(4) SHELF CARTONS WERE CONTAINED. THROUGH EVALUATION OF THE PRODUCT, THE BOXES DID SMELL OF MOISTURE. BASED ON THE PRODUCTION HISTORY RECORDS FOR THIS LOT NUMBER AND THE RETURNED SAMPLES, WE BELIEVE THAT THIS INCIDENT RESULTED FROM TRANSPORT OR STORAGE OF THE PRODUCT AFTER PRODUCTION AT THE BD MANUFACTURER. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD MICROLANCE¿ 3 NEEDLES HAD A "MOLDY" SMELL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DANISH TO ENGLISH: -THERE IS A VERY UNPLEASANT SMELL TO THIS PCN, SO I THOUGH I WOULD TREAT IS A A PRODUCT COMPLAINT. NO CUSTOMER CONTACT THEY JUST NOTICED A MOLDY SMELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD MICROLANCE¿ 3 NEEDLES HAD A "MOLDY" SMELL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DANISH TO ENGLISH: THERE IS A VERY UNPLEASANT SMELL TO THIS PCN, SO I THOUGH I WOULD TREAT IS A PRODUCT COMPLAINT. NO CUSTOMER CONTACT THEY JUST NOTICED A MOLDY SMELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514354 BD MICROLANCE¿ 3 NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220327

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown