BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ INSULIN SYRINGE

    MDR report key: 7777618 · Received August 13, 2018

    Report

    Report Number
    1920898-2018-00601
    Event Type
    Malfunction
    Date Received
    August 13, 2018
    Date of Event
    July 24, 2018
    Report Date
    August 29, 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
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (2) 1/2CC, 8MM, 30G SYRINGES WITH THE BLISTER PACK FROM LOT # 7177526. CUSTOMER STATES THAT THE BARREL IS BROKEN. BOTH RETURNED SYRINGES WERE EXAMINED AND BOTH EXHIBITED CRACKS IN THE BARREL RANGING FROM THE 25-40 UNIT MARKINGS. CAPA 162566 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS PRINT RELATED DEFECTS AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 7177526 WAS MANUFACTURED PRIOR TO INITIATION OF THIS CAPA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7177526. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWENTY NINE (29) NOTIFICATIONS (B)(4). NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE THREE (3) NOTIFICATIONS (B)(4). NOTED FOR DAMAGED BARREL. THERE WERE FOUR (4) NOTIFICATIONS (B)(4) NOTED FOR DAMAGED TIPS. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. INVESTIGATION CONCLUSION: POSSIBLE ROOT CAUSES: 1. DEFECT COULD HAVE OCCURRED AT THE PREP DIAL OF THE METRO ASSEMBLY MACHINE. LOSS OF BACK PRESSURE ON THE IN-FEED RAIL MAY CAUSE THE BARREL TO BECOME PINCHED AT THE RAIL / PREP DIAL JUNCTION. THE TRIP GATE EYE SENSOR SHOULD DETECT LOW RAIL CONDITIONS AND ACTIVATE THE TRIP GATE TO PREVENT THE BARRELS FROM BEING LOADED INTO THE PREP DIAL AND POSSIBLY JAMMING AT THAT LOCATION. 2. INFEED DIAL AT BARREL PRINTERS. 3. LOSS OF BACK PRESSURE AT INFEED RAIL ALSO AT FORM FILL & SEAL. CAPA 162566 WAS INITIATED BY THE HOLDREGE PLANT TO ADDRESS PRINT RELATED DEFECTS AND THEIR ASSOCIATED ROOT CAUSE(S). BATCH# 7177526 WAS MANUFACTURED PRIOR TO INITIATION OF THIS CAPA CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARREL OF THE BD¿ INSULIN SYRINGE WAS BROKEN. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BARREL OF THE BD¿ INSULIN SYRINGE WAS BROKEN. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620776 BD¿ INSULIN SYRINGE SYRINGE FMF BD MEDICAL - DIABETES CARE 7177526

    Patients

    Seq Age Sex Outcome Treatment
    1 Other