BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE PEN NEEDLES

    MDR report key: 18284185 · Received December 7, 2023

    Report

    Report Number
    9616656-2023-01235
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 3, 2023
    Report Date
    December 15, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMF
    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

    CORRECTION: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT MDR PR# 9335030 WAS SENT IN ERROR. COMPLAINT CAPTURED UNDER REPORT MDR PR# 8981377 MFR#9616656-2023-01076. MFR#: 9616656-2023-01235 IS VOID AS A RESULT.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. 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 THE BD ULTRA-FINE PEN NEEDLE HAD MIX PRODUCT IN A PACK. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: A PATIENT RETURNED THE PACKAGE TO THE PHARMACY STATING THAT IT CONTAINED MIXED NEEDLES IN TWO DIFFERENT SIZES. THE OFFENDING PACKAGE WAS RETURNED TO US. IT WAS SEALED WITH AN ADHESIVE TESA TAPE AND CONTAINS 132 NEEDLES, OF WHICH 72 PC 4MM NEEDLES AND 62 PC 6MM NEEDLES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE PEN NEEDLE HAD MIX PRODUCT IN A PACK. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: A PATIENT RETURNED THE PACKAGE TO THE PHARMACY STATING THAT IT CONTAINED MIXED NEEDLES IN TWO DIFFERENT SIZES. THE OFFENDING PACKAGE WAS RETURNED TO US. IT WAS SEALED WITH AN ADHESIVE TESA TAPE AND CONTAINS 132 NEEDLES, OF WHICH 72 PC 4MM NEEDLES AND 62 PC 6MM NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197450 BD ULTRA-FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMF BECTON DICKINSON AND CO. 2159730

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown