BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ STERILE LUER SLIP SYRINGE

    MDR report key: 7736896 · Received July 31, 2018

    Report

    Report Number
    3003152976-2018-00322
    Event Type
    Malfunction
    Date Received
    July 31, 2018
    Date of Event
    July 10, 2018
    Report Date
    September 5, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903031726
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 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 MANUFACTURE: NO.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. UPON VISUAL INSPECTION OF THE PICTURE SAMPLE, THE SCALE MARKINGS AND BD LOGO WERE OBSERVED MISSING FROM THE SYRINGE. A DEVICE HISTORY RECORD REVIEW FOR LOT NUMBER 1802021 REVEALED ONE ANOMALY DURING THE MANUFACTURING PROCESS. DURING THE MARKING PROCESS, A FAILURE WAS DETECTED IN THE PRINTER MACHINE THAT CAUSED INK SPOTS ON THE BARRELS. ONCE THE FAILURE WAS DETECTED, DEFECTIVE SAMPLES WERE REJECTED TO SCRAP AND THE PRINTER SYSTEM WAS REPAIRED BY THE MECHANICAL TEAM AND CLEANED. EVERY TIME THE PRINTER SYSTEM IS CLEANED, THE OPERATOR MUST REJECT THE FIRST PIECES TO SCRAP UNTIL THE MARKING ON THE BARRELS IS CORRECT. THIS REJECTION PROCESS WAS NOT CORRECTLY FOLLOWED BY THE OPERATOR. THE CAUSE OF THIS DEFECT HAS BEEN IDENTIFIED AS HUMAN ERROR AFTER MECHANICAL INTERVENTION. BASED ON OCCURRENCE IT WAS DETERMINED NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK STERILE LUER SLIP SYRINGE THERE WAS AN ISSUE WITH LABELING ERROR. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ STERILE LUER SLIP SYRINGE THERE WAS AN ISSUE WITH LABELING ERROR. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    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 WITH THE USE OF THE BD PLASTIPAK¿ STERILE LUER SLIP SYRINGE THERE WAS AN ISSUE WITH LABELING ERROR. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577954 BD PLASTIPAK¿ STERILE LUER SLIP SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON, S.A. 1802021 00382903031726

    Patients

    Seq Age Sex Outcome Treatment
    1 Other