BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLE

    MDR report key: 8890869 · Received August 13, 2019

    Report

    Report Number
    9616656-2019-00742
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    July 26, 2019
    Report Date
    September 4, 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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. 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. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: -UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE SECTION H.10

    Description of Event or Problem · 0

    MATERIAL NO. 320119. BATCH NO. 9022887. IT WAS REPORTED THAT DURING USE OF THE BD ULTRA FINE¿ PEN NEEDLE THE NEEDLE CLOGGED DURING INJECTION. ONLY EIGHT UNITS OUT OF THE TEN WERE DELIVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED DURING HIS INJECTION THIS MORNING, INSULIN FLOW STOPPED BEFORE HE COULD COMPLETE HIS 10 UNITS. HE ONLY RECEIVED 8 UNITS OF INSULIN. HE DID NOT USE A SECOND PEN NEEDLE TO GET ADDITIONAL 2 UNITS. DOES PRIME BEFORE USE

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 320119, BATCH NO. 9022887. IT WAS REPORTED THAT DURING USE OF THE BD ULTRA FINE¿ PEN NEEDLE THE NEEDLE CLOGGED DURING INJECTION. ONLY EIGHT UNITS OUT OF THE TEN WERE DELIVERED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED DURING HIS INJECTION THIS MORNING, INSULIN FLOW STOPPED BEFORE HE COULD COMPLETE HIS 10 UNITS. HE ONLY RECEIVED 8 UNITS OF INSULIN. HE DID NOT USE A SECOND PEN NEEDLE TO GET ADDITIONAL 2 UNITS. DOES PRIME BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684112 BD ULTRA FINE¿ PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 9022887 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other