BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE 3/10ML 29G X 8MM

    MDR report key: 13845835 · Received March 22, 2022

    Report

    Report Number
    1920898-2022-00176
    Event Type
    Malfunction
    Date Received
    March 22, 2022
    Date of Event
    March 4, 2022
    Report Date
    April 19, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    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

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED A TOTAL OF 47 SYRINGES. 40 OF THESE SYRINGES WERE RETURNED IN UNOPENED POLYBAGS LABELED FOR 0.3ML, 31 GAUGE, 8MM SYRINGES FROM LOT 1242440. THE REMAINING 7 WERE 0.3ML BUT WERE NOT RETURNED WITH ANY IDENTIFYING POLYBAG. 30 OF THESE SAMPLES WERE MEASURED. EACH OF THE SYRINGES INSPECTED AND OF THEIR GRADUATION MARKINGS. THE POSITION OF THE GRADUATION MARKINGS WERE ALL FOUND TO BE WITHIN SPECIFICATIONS. NONE OF THE MARKINGS WERE FOUND TO TILT SIGNIFICANTLY, AND NONE WERE FOUND TO DEVIATE IN A MANNER THAT WOULD PLACE THE MARKINGS OUTSIDE OF SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1242440. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF DEFECTIVE SCALE MARKINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION INSULIN SYRINGE 3/10ML 29G X 8MM THE SCALE MARKINGS WERE SLANTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BOTH BOXES FOUND SLANTED SCALE MARKINGS ON THE SYRINGES, MISS DOSED THE DOG AND HE TESTED HIGH WITH THESE SYRINGES USE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION INSULIN SYRINGE 3/10ML 29G X 8MM THE SCALE MARKINGS WERE SLANTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BOTH BOXES FOUND SLANTED SCALE MARKINGS ON THE SYRINGES, MISS DOSED THE DOG AND HE TESTED HIGH WITH THESE SYRINGES USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588735 RELION INSULIN SYRINGE 3/10ML 29G X 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 1242440 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown