BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10221865 · Received July 1, 2020

    Report

    Report Number
    9616656-2020-00616
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 12, 2020
    Report Date
    June 23, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403811012
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION - COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST. RELATED COMPLAINT FOR BENDING DURING USE PE, NPI NEEDLE PAIN, HARM BRUISING & NEEDLE CLOG ON LOT # 9121955. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4) REVISION 18, INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (PEN NEEDLE: BENDING DURING USE PE, NPI NEEDLE PAIN & NEEDLE CLOG) WAS CAPTURED AND ADDRESSED APPROPRIATELY. THE REPORTED HARM, BRUISING IS DIRECTLY ASSOCIATED WITH HAZARD: NPI (NEEDLE POINT INTEGRITY); THIS IS CAPTURED IN RISK ASSESSMENT FILE (B)(4) REVISION 18. INVESTIGATION SUMMARY: NO SAMPLES 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 CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: 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. 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. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320119 BATCH NO. 9121955. VERBATIM: CONSUMER REPORTED SOME PEN NEEDLES FROM CURRENT BOX ARE BENDING DURING HIS INJECTIONS. STATED HE IS ALSO EXPERIENCING PAIN DURING HIS INJECTIONS AND SOME BRUISING AT THE INJECTION SITES. ALSO STATED HE FEELS HE IS NOT GETTING A GOOD INSULIN FLOW. DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680372 BD ULTRA-FINE MINI PEN NEEDLES 5MM (3/16) 31G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8110 9121955 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other