BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 0.5ML 0.30MM (30G) X 8MM

    MDR report key: 15184206 · Received August 8, 2022

    Report

    Report Number
    1920898-2022-00523
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    July 11, 2022
    Report Date
    August 16, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K970737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 1172445 FOR INCORRECT/MISSING INFORMATION (LOT #). THIS IS THE 1ST. RELATED COMPLAINT FOR INCORRECT/MISSING INFORMATION (LOT #) ON LOT #1172445. CUSTOMER RETURNED SEVERAL OF IMAGES OF SHELF CARTONS FOR 0.5ML, 30 GAUGE, 8MM SYRINGES FROM LOT 1772445. THE SHELF CARTONS SHOWN FEATURE A SCUFFED REGION AND SEVERAL CRUMPLED AREAS. ADDITIONALLY, ONE SHELF CARTON IS MISSING THE PRINTED LOT AND MANUFACTURING INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #1172445. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF MISSING MANUFACTURING INFORMATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 0.5ML 0.30MM (30G) X 8MM VARIOUS ASPECTS OF THE LABELLING INFORMATION WERE MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO VENDOR LOT & NO EXPIRY DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 0.5ML 0.30MM (30G) X 8MM VARIOUS ASPECTS OF THE LABELLING INFORMATION WERE MISSING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO VENDOR LOT & NO EXPIRY DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2297649 BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE 0.5ML 0.30MM (30G) X 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1172445

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown