BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ MINI PEN NEEDLE

    MDR report key: 8493361 · Received April 8, 2019

    Report

    Report Number
    9616656-2019-00322
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    March 22, 2019
    Report Date
    May 7, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403811012
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ MINI PEN NEEDLE WAS MISSING THE LABEL. THIS OCCURRED ON 6 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320119, BATCH NO. 8143543. IT WAS REPORTED THAT 6 PEN NEEDLES WERE MISSING THE NEEDLE. ALSO SOME NEEDLES WERE MISSING THE TEAR DROP LABEL. VERBATIM: CONSUMER REPORTED SHE FOUND 6 MISSING NEEDLES FROM THE PEN NEEDLE. THERE WAS NO LABEL BUT ONLY PLASTIC LEFT. SHE ALSO NOTICED NEEDLE WAS MISSING WHEN SHE WENT TO INJECT. SHE DOES PRIMING, BUT NOT IF THERE'S NO NEEDLE. SAMPLE DISCARDED. INCIDENT DATE-UNKNOWN;LOT-8143543;EXPIRATION DATE-2023-05-31;ITEM#-320119; IT HAS HAPPENED IN THE PAST, SHE GAVE THE BOX TO THE PHARMACY, LOT# NOT AVAILABLE, SAMPLE DISCARDED. QUANTITY-UNKNOWN. OFFER TO SEND THE VOUCHER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8143543; MEDICAL DEVICE EXPIRATION DATE: 2023-05-31; DEVICE MANUFACTURE DATE: 2018-05-23; MEDICAL DEVICE LOT #: UNKNOWN; MEDICAL DEVICE EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ MINI PEN NEEDLE WAS MISSING THE LABEL. THIS OCCURRED ON 6 SEPARATE OCCASIONS. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320119, BATCH NO. 8143543. IT WAS REPORTED THAT 6 PEN NEEDLES WERE MISSING THE NEEDLE. ALSO SOME NEEDLES WERE MISSING THE TEAR DROP LABEL. VERBATIM: CONSUMER REPORTED SHE FOUND 6 MISSING NEEDLES FROM THE PEN NEEDLE. THERE WAS NO LABEL BUT ONLY PLASTIC LEFT. SHE ALSO NOTICED NEEDLE WAS MISSING WHEN SHE WENT TO INJECT. SHE DOES PRIMING, BUT NOT IF THERE'S NO NEEDLE. SAMPLE DISCARDED. INCIDENT DATE-UNKNOWN; LOT-8143543; EXPIRATION DATE-2023-05-31; ITEM#-320119; IT HAS HAPPENED IN THE PAST, SHE GAVE THE BOX TO THE PHARMACY, LOT# NOT AVAILABLE, SAMPLE DISCARDED. QUANTITY-UNKNOWN. OFFER TO SEND THE VOUCHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283391 BD ULTRA-FINE¿ MINI PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other