BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP

    MDR report key: 8744161 · Received June 28, 2019

    Report

    Report Number
    1917413-2019-01664
    Event Type
    Injury
    Date Received
    June 28, 2019
    Date of Event
    June 7, 2019
    Report Date
    June 14, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 8092781 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. 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. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TYPE 1 DIABETIC PATIENT INJECTED HERSELF WITH INSULIN VIA THE SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP INTO THE ABDOMEN, AND FOUND THE NEEDLE WAS MISSING WHEN WITHDRAWING THE SYRINGE AFTER USE, BELIEVING IT BE EMBEDDED IN THE SUBCUTANEOUS FAT LAYER. THE CONSUMER REPORTEDLY VISITED THE ER AND GOT AN X-RAY OF THE ABDOMEN, BUT THE NEEDLE WAS NOT FOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A T1DM PATIENT INJECTED INSULIN INTO HER ABDOMEN AND FOUND OUT THAT THE NEEDLE WAS NO NEEDLE WHEN WITHDRAW THE SYRINGE FROM HER INJECTION SITE. NEEDLE WAS EMBEDDED IN HER SQ FAT LAYER. SHE WENT TO EMERGENCY ROOM AND TOOK X-RAY BUT DIDN'T FIND THE NEEDLE. CURRENTLY EXPERIENCE NO PAIN BUT VERY ANXIOUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540145 SYRINGE 1.0ML 30GA 8MM 7BAG 420CAS JP SYRINGE FMF BD MEDICAL - DIABETES CARE 8092781

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention