BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 19893685 · Received August 2, 2024

    Report

    Report Number
    3024508819-2024-00239
    Event Type
    Injury
    Date Received
    August 2, 2024
    Report Date
    October 24, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    K190054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: EMBECTA ACKNOWLEDGES AND APPRECIATES THE CONCERN REGARDING AN ALLEGED ADVERSE EVENT ASSOCIATED WITH OUR SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL DEVICE. WE VALUE OUR COMMITMENT TO PATIENT SAFETY AND TAKE ALL COMPLAINTS SERIOUSLY. HOWEVER, AFTER A THOROUGH REVIEW, IT HAS BEEN DETERMINED THAT THE COMPLAINT CANNOT BE FURTHER INVESTIGATED DUE TO INSUFFICIENT INFORMATION AFTER OUTREACH ATTEMPTS TO THE REPORTER BY THE POST-MARKET VIGILANCE TEAM. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST. COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    CONSUMER REPORTED THAT HIS SYRINGES ARE CONTAMINATED. HE STATED THAT IMMEDIATELY AFTER USING THE SYRINGE FOR HIS B-12 INJECTION HE BECAME ILL. THE SYMPTOMS HE MENTIONED ARE: BLOOD IN URINE, BLOOD IN STOOL, BOWEL CHANGES, KIDNEY FAILURE, LIVER DAMAGE, CHEST PAINS AND BLOOD CLOTS IN HIS LUNGS. CONSUMER STATED THAT THE ISSUE OCCURRED IN 2022 AND HE IS STILL BEING TREATED. CONSUMER BELIEVES THAT SOMEONE CONTAMINATED THE SYRINGES. HE SAID HE NOTICED THAT HIS BLOOD CLOTTED VERY QUICKLY AFTER HE TESTED THE SYRINGE BY PULLING BLOOD FROM HIS VEIN INTO THE SYRINGE. CONSUMER ALSO STATED THAT HE GAVE SOME OF THE SYRINGES TO HIS FRIENDS AND ONE OF HIS FRIENDS DIED A SHORT WHILE AFTER USING THE SYRINGE. HE SAID THE FRIEND WAS USING THE SYRINGE FOR DRUGS. LOT #: 8190574. CATALOG #: 328506. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958853 SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328506 8190574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male