BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9172329 · Received October 9, 2019

    Report

    Report Number
    9616656-2019-00969
    Event Type
    Malfunction
    Date Received
    October 9, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 21, 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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (22) OPEN 5MM, 31G PEN NEEDLES WITHOUT THE TEAR DROP LABEL. CUSTOMER STATES THAT SHE'S NOT ABLE TO ATTACH SOME OF THE PEN NEEDLES TO INSULIN PEN FROM THIS BOX. ALL RETURNED PEN NEEDLES WERE EXAMINED AND NO BENT CANNULA WAS OBSERVED. ALL SAMPLES WERE ALSO TESTED AND ALL WERE ABLE TO SECURELY ATTACH AND EASILY DETACH FROM A PEN WITHOUT ANY OBSERVED DEFECTS. 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. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G EXPERIENCED INNER SHIELD OR OUTER COVER/CAP DOES NOT ATTACH/DETACH DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320119, BATCH NO: 9071856. VERBATIM: EXPIRATION DATE: 2024-03-31. INCIDENT DATE: UNKNOWN. SPOUSE OF CONSUMER REPORTED, SHE'S NOT ABLE TO ATTACH SOME OF THE PEN NEEDLES TO INSULIN PEN FROM THIS BOX. STATED, THE NON PATIENT END, IN NOT BENT. FIRST TIME SHE'S HAD ISSUE WITH PRODUCT. REPORTED THE PROBLEM TO PHARMACIST, WHO TOLD HER TO CALL BD. SHE RAN OUT OF PEN NEEDLES TRYING TO FIND ONE THAT WORKS IN THE BOX. PHARMACIST AGREED TO GIVE A REPLACEMENT BOX.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G EXPERIENCED INNER SHIELD OR OUTER COVER/CAP DOES NOT ATTACH/DETACH DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320119 BATCH NO: 9071856. VERBATIM: EXPIRATION DATE: 2024-03-31. INCIDENT DATE: UNKNOWN. SPOUSE OF CONSUMER REPORTED, SHE'S NOT ABLE TO ATTACH SOME OF THE PEN NEEDLES TO INSULIN PEN FROM THIS BOX. STATED, THE NON PATIENT END, IN NOT BENT. FIRST TIME SHE'S HAD ISSUE WITH PRODUCT. REPORTED THE PROBLEM TO PHARMACIST, WHO TOLD HER TO CALL BD. SHE RAN OUT OF PEN NEEDLES TRYING TO FIND ONE THAT WORKS IN THE BOX. PHARMACIST AGREED TO GIVE A REPLACEMENT BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964617 BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G PEN NEEDLE FMI BECTON DICKINSON AND CO. 9071856 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other