BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 8457722 · Received March 27, 2019

    Report

    Report Number
    9616656-2019-00279
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Date of Event
    March 8, 2019
    Report Date
    March 29, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTION IS AS FOLLOWS: REASON CODE FOR NO EVALUATION: OTHER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD ULTRA FINE¿ PEN NEEDLES HAD PLUNGER THAT WOULD NOT MOVE DURING INJECTION. THE FOLLOWING WAS REPORTED: " MATERIAL NO: 320122 BATCH NO: 8130794. IT WAS REPORTED: THAT THE PLUNGER ON PEN WILL NOT MOVE DURING INJECTION. ITEM # 320122 LOT # 8130794, EXP 2023-05-31. CALLER IS CALLING FOR DAD PLUNGER ON PEN WILL NOT MOVE DURING INJECTION DISCARDED SENDING VOUCHER AND REBATE. UNKNOWN OCCD DATE"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD ULTRA FINE¿ PEN NEEDLES HAD PLUNGER THAT WOULD NOT MOVE DURING INJECTION. THE FOLLOWING WAS REPORTED, " MATERIAL NO: 320122; BATCH NO: 8130794. IT WAS REPORTED: THAT THE PLUNGER ON PEN WILL NOT MOVE DURING INJECTION VERBATIM: ITEM # 320122, LOT # 8130794, EXP 2023-05-31 CALLER IS CALLING FOR DAD PLUNGER ON PEN WILL NOT MOVE DURING INJECTION DISCARDED SENDING VOUCHER AND REBATE. UNKNOWN OCCD DATE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247860 BD ULTRA FINE¿ PEN NEEDLES PEN NEEDLE FMI BECTON DICKINSON AND CO. 8130794

    Patients

    Seq Age Sex Outcome Treatment
    1 Other