BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G

    MDR report key: 17095590 · Received June 9, 2023

    Report

    Report Number
    9616656-2023-00565
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 18, 2023
    Report Date
    June 29, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403811012
    PMA / PMN Number
    K023264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2130196 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2027 H.4. DEVICE MANUFACTURE DATE: 10-MAY-2022 D.4. MEDICAL DEVICE LOT #: 2116276 D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027 H.4. DEVICE MANUFACTURE DATE: 26-APR-2022.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G WERE UNABLE TO DELIVER MEDICATION. LOT#"S 2130196, 2116276 THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, STATED THAT THERE IS NO INSULIN FLOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G WERE UNABLE TO DELIVER MEDICATION. LOT#"S 2130196, 2116276. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, STATED THAT THERE IS NO INSULIN FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550992 BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8110 SEE H.10 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown