BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 16858186 · Received May 3, 2023

    Report

    Report Number
    1920898-2023-00275
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    March 28, 2023
    Report Date
    February 16, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    UDI-DI
    00382903059508
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: SEE B5 FOLLOW UP RECEIVED FROM CUSTOMER. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 4TH 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSULIN SYRINGES WERE FOUND MIXED IN WITH THE ALLERGY SYRINGES IN THE BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER ORDERS FROM ALK, RECEIVED INSULIN SYRINGES WITH THE ALLERGY SYRINGES (MIXED PRODUCT) STATED THAT SOME ARE ALL ALLERGY (CORRECT) SOME WILL HAVE ALLERGY AND INSULIN SYRINGES."

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 01-MAY-2023. 1. STAFF SAVED 16 UNUSED SYRINGES, USED INSULIN SYRINGES WERE DISCARDED INTO SHARPS CONTAINERS. 2. I NOTIFIED OUR (B)(6) REPRESENTATIVE MARCH 28, 2023. 3. THE INJECTION NURSE NOTIFIED ME SHE WAS GIVING AN ALLERGY INJECTION AND NOTICED AFTER SHE GAVE THE INJECTION IT WAS AN INSULIN SYRINGE. I PURCHASE A STANDING ORDER OF 4 CASES OF THE BD SAFETY GLIDE FROM (B)(6) EACH MONTH. IT WAS RANDOM WHICH ALLERGY TRAY OF 25 SYRINGES CONTAINED THE INSULIN SYRINGES MIXED IN WITH THE ALLERGY SYRINGES. ALL SYRINGES CAME FROM LOT 2221215. NO ADVERSE EVENT OR INJURY REPORTED. 4. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151849 BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE PISTON SYRINGE MEG BD MEDICAL - DIABETES CARE 2221315 00382903059508

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown