BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 8MM 100 BX 1200 USA

    MDR report key: 10979754 · Received December 9, 2020

    Report

    Report Number
    9616656-2020-01247
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 16, 2020
    Report Date
    January 25, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201099
    PMA / PMN Number
    K051641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: 2020-12-28. INVESTIGATION SUMMARY: CUSTOMER RETURNED (B)(4) SEALED 8MM, 31G PEN NEEDLES FROM LOT # 0022816. CUSTOMER STATES THAT DURING THE INJECTION, THE PATIENT END IS BREAKING OFF INTO THE SITE. (B)(4) RETURNED PEN NEEDLES WERE EXAMINED AND NO BROKEN CANNULA OR ANY OTHER DEFECTS WAS OBSERVED. 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. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 31GA 8MM 100 BX 1200 USA BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT DURING THE INJECTION, THE PATIENT END IS BREAKING OFF INTO THE SITE. VERBATIM: CONSUMER REPORTED, DURING INJECTION, PATIENT END IS BREAKING OFF IN THE SITE. STATED, HE WAS ABLE TO REMOVE THE NEEDLE BY USING A TWEEZER. STATED, NO BRUISING AND HE DID NOT SEEK MEDICAL ATTENTION. STATED, THIS IS THE FIRST TIME HE'S HAD AN ISSUE WITH THE PRODUCT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 A PEN NDL 31GA 8MM 100 BX 1200 USA BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT DURING THE INJECTION, THE PATIENT END IS BREAKING OFF INTO THE SITE. VERBATIM: CONSUMER REPORTED, DURING INJECTION, PATIENT END IS BREAKING OFF IN THE SITE STATED, HE WAS ABLE TO REMOVE THE NEEDLE BY USING A TWEEZER STATED, NO BRUISING AND HE DID NOT SEEK MEDICAL ATTENTION STATED, THIS IS THE FIRST TIME HE'S HAD AN ISSUE WITH THE PRODUCT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440391 PEN NDL 31GA 8MM 100 BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320109 0022816 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1