BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 G X 1 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6892120 · Received September 25, 2017

    Report

    Report Number
    8041187-2017-00118
    Event Type
    Malfunction
    Date Received
    September 25, 2017
    Date of Event
    July 31, 2017
    Report Date
    October 24, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE PICTURE RECEIVED AND ONE ACTUAL SAMPLE WITHOUT PACKAGING WAS RETURNED FOR INVESTIGATION. OBSERVED THE SYRINGE BARREL WAS DAMAGED. DHR REVIEW: NO ABNORMALITY AND QN REPORTED DURING ECLIPSE ASSEMBLY PRODUCTION. REVIEWED SYRINGE DHR FOR CATALOGUE# S20351SGT, BATCH# 7142288, 7087209, 7108087, 7142041, 7115368. NO QUALITY NOTIFICATION WAS RAISED FOR ALL THE BATCHES ON THE REPORTED NONCONFORMANCE. NO SIMILAR NONCONFORMANCE WAS DETECTED IN IN-PROCESS AND OUTGOING INSPECTION. INVESTIGATION CONCLUSION: ONE PICTURE AND ONE ACTUAL SAMPLE WITHOUT PACKAGING RECEIVED. WE OBSERVED DAMAGE ON THE SYRINGE BARREL. ROOT CAUSE DESCRIPTION: PROBABLE CAUSE COULD BE DUE TO POOR THROW OUT OF THE ASSEMBLED SYRINGE AT THE AUTO-REJECT STATION. THE BARREL COULD HAVE BEEN SLANTED AND HIT THE SIDE GUIDE RESULTING IN DAMAGE BARREL. CAPA# (B)(4) HAD BEEN INITIATED TO ADDRESS DAMAGED SYRINGE NONCONFORMANCE.

    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. (B)(4).

    Description of Event or Problem · 1

    IT AS REPORTED THAT THE BARREL ON A 23 G X 1 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE WAS CRACKED WHICH COULD LEAD TO LEAKAGE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670890 23 G X 1 IN. BD ECLIPSE¿ 3 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 7135159

    Patients

    Seq Age Sex Outcome Treatment
    1 Other