BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD AUTOSHIELD DUO PEN NEEDLE 30GX5MM

    MDR report key: 5763449 · Received June 30, 2016

    Report

    Report Number
    9610847-2016-00017
    Event Type
    Injury
    Date Received
    June 30, 2016
    Date of Event
    June 1, 2016
    Report Date
    September 1, 2016
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMI
    PMA / PMN Number
    K110703
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A SAMPLE HAS BEEN RETURNED FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CORRECTION: MEDICAL DEVICE LOT NUMBER: THE INITIAL MDR WAS SUBMITTED WITH LOT 5068701. THE CUSTOMER HAS SINCE REPORTED THAT THE ACTUAL LOT NUMBER INVOLVED IN THIS INCIDENT IS UNKNOWN. ALTHOUGH THE LOT NUMBER FOR THIS INCIDENT IS UNKNOWN, THE CUSTOMER RETURNED SAMPLES FOR THE FOLLOWING POTENTIAL LOT NUMBERS AS THESE WERE SOME OF THE LOTS FOUND IN THEIR FACILITY: 5068701 - REPORTED ON INITIAL; 5077830 - MEDICAL DEVICE EXPIRATION DATE 02/28/2018, DEVICE MANUFACTURE DATE 03/18/2015; 5068708 - MEDICAL DEVICE EXPIRATION DATE 02/28/2018, DEVICE MANUFACTURE DATE 03/09/2015; 5029713 - MEDICAL DEVICE EXPIRATION DATE 12/31/2017, DEVICE MANUFACTURE DATE 01/29/2015; 4009015 - MEDICAL DEVICE EXPIRATION DATE 12/31/2016, DEVICE MANUFACTURE DATE 01/09/2014; 3353194 - MEDICAL DEVICE EXPIRATION DATE 12/31/2016, DEVICE MANUFACTURE DATE 12/19/2013; 4091200 - MEDICAL DEVICE EXPIRATION DATE 03/31/2017, DEVICE MANUFACTURE DATE 04/01/2014; 4286140 - MEDICAL DEVICE EXPIRATION DATE 09/30/2017, DEVICE MANUFACTURE DATE 10/13/2014; 4206100 - MEDICAL DEVICE EXPIRATION DATE 06/30/2017, DEVICE MANUFACTURE DATE 07/25/2014; 4206097 - MEDICAL DEVICE EXPIRATION DATE 06/30/2017, DEVICE MANUFACTURE DATE 07/25/2014; 4252104 - MEDICAL DEVICE EXPIRATION DATE 08/31/2017, DEVICE MANUFACTURE DATE 09/09/2014. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULT - THE CUSTOMER RETURNED (284) SEALED 5MM, 30G AUTOSHIELD DUO SAMPLES (37 FROM LOT # 5068701, 10 FROM LOT # 3353194, 59 FROM LOT # 5029713, 38 FROM LOT # 5068708, 17 FROM LOT # 4252104, 14 FROM LOT # 4009015, 15 FROM LOT # 4206097, 35 FROM LOT # 5077830, 27 FROM LOT # 4091200, 15 FROM LOT # 4286140, AND 17 FROM LOT # 4206100). ALL RETURNED SAMPLES FROM ALL RETURNED LOT NUMBERS WERE TESTED AND ALL WERE ABLE TO ACTIVATE PROPERLY WITHOUT ANY OBSERVED DEFECTS. SINCE ALL SAMPLES ACTIVATED PROPERLY, NO EXPOSED NEEDLE WAS OBSERVED ON ANY OF THE SAMPLES AND A NEEDLE STICK WAS NOT POSSIBLE ON THE RETURNED SAMPLES. CONCLUSION - BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBERS. OF NOTE, IT IS UNKNOWN IF SAMPLES FROM THE LOT NUMBER INVOLVED IN THIS INCIDENT WERE RETURNED AS THE ACTUAL DEVICE USED WAS DISCARDED WITH THE PACKAGING. THE CUSTOMER RETURNED SAMPLES FROM SOME OF THE LOTS REMAINING IN THEIR FACILITY.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED POTENTIAL LOT NUMBERS 5068701, 5029713, 4009015, 3353194, 4091200, 4286140, 4206100, 4206097 AND 4252104. FOR LOT 5077830, NO ABNORMALITIES WERE NOTED DURING THE MANUFACTURING PROCESS EXCEPT ONE QN THAT WAS ISSUED DUE TO A NOT FULLY ASSEMBLY BETWEEN THE HUB AND SLEEVE. A ROOT CAUSE COULD NOT BE DETERMINED AND PISTON LENGTH WAS ADJUSTED TO OBTAIN THE CORRECT ASSEMBLY BETWEEN HUB AND SLEEVE. FOR LOT 5068708, NO ABNORMALITIES WERE NOTED DURING THE MANUFACTURING PROCESS EXCEPT ONE QN THAT WAS ISSUED DUE TO A CANNULA DAMAGED. THE ROOT CAUSE WAS DETERMINED TO BE A DAMAGED SPEED VALVE REGULATOR AND CORRECTIVE ACTIONS WERE TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICIAN ADMINISTERED A SUBCUTANEOUS NOVOLOG INSULIN PEN INJECTION USING THE SUSPECT DEVICE. FOLLOWING THE INJECTION, SHE WENT TO UNSCREW THE DEVICE BUT THE NEEDLE HAD FAILED TO RETRACT AND THE CLINICIAN RECEIVED A NEEDLE STICK INJURY TO THE PALM OF HER HAND. THE CLINICIAN WENT TO THE EMERGENCY DEPARTMENT AND FOLLOWED UP WITH EMPLOYEE HEALTH. SHE RECEIVED POST EXPOSURE LAB WORK BUT NO PROPHYLACTIC MEDICATIONS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415108 BD AUTOSHIELD DUO PEN NEEDLE 30GX5MM SAFETY INSULIN PEN NEEDLE FMI BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention