BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE

    MDR report key: 8026206 · Received October 31, 2018

    Report

    Report Number
    1920898-2018-00813
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 6, 2018
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DEVICE HISTORY RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7240672. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. SYRINGE ASSEMBLY ¿ THERE WAS ONE (1) BATCH OF MATERIAL# 700003985 (SYRINGE 1.0ML ASM 30GA 8MM TW SM700177) THAT WENT INTO FINISHED BATCH# 7240672. BATCH # 7240672 WAS MANUFACTURED ON 16OCT2017 TO 17OCT2017. THERE WAS ONE (1) NOTIFICATION [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR BARREL BENDING DURING USE AND PLUNGER ROD DIFFICULT TO MOVE ON LOT # 7240672. 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 SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE, THE BARREL BENDS AND THE RUBBER PLUNGER GETS STUCK WHEN DEPRESSING . THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE, THE BARREL BENDS AND THE RUBBER PLUNGER GETS STUCK WHEN DEPRESSING . THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863124 BD¿ ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 7240672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other