BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 12.7MM (1/2")

    MDR report key: 15470612 · Received September 23, 2022

    Report

    Report Number
    1920898-2022-00642
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    August 29, 2022
    Report Date
    November 17, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 30-SEP-2022 H6: INVESTIGATION SUMMARY USTOMER RETURNED (10) 30GX12.7MM, 0.5ML BD INSULIN SYRINGES IN AN UNOPENED POLYBAG FROM LOT# 2083765. THE CUSTOMER REPORTED FINDING THE NEEDLE LENGTHS TO BE ¾¿ AND NOT ½¿. THE SAMPLES WERE EXAMINED, THEN TESTED FOR CANNULA LENGTH AND THE FOLLOWING WAS OBSERVED (SPECS: LENGTH FOR 6MM CANNULA: 0.451¿-0.549¿): DATA: CANNULA LENGTH (INCH.) SAMPLE 1 0.456 SAMPLE 2 0.459 SAMPLE 3 0.458 SAMPLE 4 0.461 SAMPLE 5 0.456 SAMPLE 6 0.459 SAMPLE 7 0.468 SAMPLE 8 0.463 SAMPLE 9 0.454 SAMPLE 10 0.470 ALL OBSERVATIONS FELL WITHIN SPECIFICATION. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE ALLEGED DEFECT COULD NOT BE CONFIRMED BASED ON THE SAMPLES PROVIDED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2083765. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 12.7MM (1/2") THE CANNULA LENGTH WAS INCORRECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING THE NEEDLES LENGTHS TO BE 3/4" AND NOT 1/2". SO FAR FIRST 2 BAGS OUT OF BOX.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 12.7MM (1/2") THE CANNULA LENGTH WAS INCORRECT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING THE NEEDLES LENGTHS TO BE 3/4" AND NOT 1/2". SO FAR FIRST 2 BAGS OUT OF BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568313 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 12.7MM (1/2") PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2083765

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown