BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 7926396 · Received October 2, 2018

    Report

    Report Number
    1920898-2018-00753
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Date of Event
    September 10, 2018
    Report Date
    October 9, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) LOOSE 3/10CC SYRINGES WITH NO PACKAGING. CUSTOMER STATES THAT THEY FOUND TWO DIFFERENT SIZE NEEDLES ON HER SYRINGES. BOTH RETURNED SYRINGES WERE TESTED USING THE LENGTH GAUGE AND ONE SAMPLE FELL WITHIN SPECIFICATIONS FOR 8MM CANNULA LENGTH. THE REMAINING SAMPLE FELL WITHIN SPECIFICATIONS FOR 12.7MM CANNULA LENGTH. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 7240810 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS [200719340, 200719497, 200719065, 200711711, 200711496] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO PACKAGING WAS RETURNED WITH THE SAMPLES TO DETERMINE WHICH BATCH THE SAMPLES CAME FROM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD MIXED PRODUCT IN PACKAGING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD MIXED PRODUCT IN PACKAGING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767478 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7240810 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other