BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 5MM 100BX 1200 USA

    MDR report key: 11346661 · Received February 18, 2021

    Report

    Report Number
    9616656-2021-00161
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 25, 2021
    Report Date
    April 13, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201198
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-18. INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) OPEN 5MM, 31G PEN NEEDLES WITHOUT THE TEAR DROP LABEL AND (1) PEN NEEDLE THAT IS NOT A BD PRODUCT. CUSTOMER STATES THAT THE NEEDLES ARE DULL. BOTH RETURNED BD PEN NEEDLES WERE TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 31G: 0.0100¿-0.0105¿): DATA: POINT OUTER DIAMETER (IN) LUBE SAMPLE 1: GOOD, 0.0103, GOOD. SAMPLE 2: GOOD, 0.0101, GOOD. ALL OBSERVATIONS FALL WITHIN SPECIFICATIONS. CUSTOMER RETURNED (2) OPEN 5MM, 31G PEN NEEDLES WITHOUT THE TEAR DROP LABEL AND (1) PEN NEEDLE THAT IS NOT A BD PRODUCT. CUSTOMER STATES THAT THE OUTER COVER WILL NOT ATTACH TO PEN NEEDLE. BOTH RETURNED BD PEN NEEDLES WERE TESTED AND BOTH 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 31GA 5MM 100BX 1200 USA HAD THE OUTER COVER UNABLE TO ATTACH TO THE PEN DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT OUTER COVER WILL NOT ATTACH TO PEN NEEDLE AND NEEDLES ARE ALSO DULL. VERBATIM: CONSUMER REPORTED USING BD PEN NEEDLE ON RADIUS MEDICAL PEN TYMLOS. CALLER STATED NEEDS TO REMOVE PEN NEEDLE FROM THIS PEN USING JUST HER FINGERS AND NOT THE OUTER COVER. THE OUTER COVER WILL NOT ATTACH TO THE PEN NEEDLE WHEN REMOVING FROM PEN. CONSUMER STATED THE MEDICATION AND PEN NEEDLES ARE SHIPPED IN A DEEP COLD PACKAGE FOR 24 - 48 HOURS AND TEMPS MIGHT HAVE SOME CONFLICT WITH THE PLASTIC OF THE PEN NEEDLES. CONSUMER REPORTED NEEDLES ARE ALSO AT TIMES DULL".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0112339, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-04-21. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 31GA 5MM 100BX 1200 USA HAD THE OUTER COVER UNABLE TO ATTACH TO THE PEN DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT OUTER COVER WILL NOT ATTACH TO PEN NEEDLE AND NEEDLES ARE ALSO DULL. VERBATIM: CONSUMER REPORTED USING BD PEN NEEDLE ON RADIUS MEDICAL PEN TYMLOS. CALLER STATED NEEDS TO REMOVE PEN NEEDLE FROM THIS PEN USING JUST HER FINGERS AND NOT THE OUTER COVER. THE OUTER COVER WILL NOT ATTACH TO THE PEN NEEDLE WHEN REMOVING FROM PEN. CONSUMER STATED THE MEDICATION AND PEN NEEDLES ARE SHIPPED IN A DEEP COLD PACKAGE FOR 24 - 48 HOURS AND TEMPS MIGHT HAVE SOME CONFLICT WITH THE PLASTIC OF THE PEN NEEDLES CONSUMER REPORTED NEEDLES ARE ALSO AT TIMES DULL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240776 PEN NDL 31GA 5MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320119 SEE H.10. 00382903201198

    Patients

    Seq Age Sex Outcome Treatment
    1