BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB

    MDR report key: 8861640 · Received August 5, 2019

    Report

    Report Number
    8041187-2019-00608
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 30, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057895
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR WAS PERFORMED AND WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ONE PHOTO AND ONE 1ML SYRINGE WITH AN ECLIPSE NEEDLE ASSEMBLY IN AN OPENED BLISTER PACK FROM BATCH 8052070 (P/N (B)(4)) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WAS MULTIPLE SCRATCHES AND INDENTATIONS ON AND BELOW THE FLANGE. THERE WAS ALSO A SCRATCH NEAR THE BOTTOM ABOVE THE COLLAR. IT WAS ALSO OBSERVED THE SCALE ON THE SYRINGE WAS SEVERELY SKEWED AND SMEARED TO THE POINT IT WAS ALMOST COMPLETELY ILLEGIBLE AND WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE SKEWED SCALE DEFECT IS ASSOCIATED WITH THE PRINTING PROCESS. THIS WAS MOST LIKELY FROM THE PRINT PAD BEING IN THE WRONG POSITION CAUSING THE PRINT TO BE APPLIED AT AN ANGLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SCALE MARKING ISSUE OCCURRED BEFORE USE WITH A SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SCALE MISSING".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: FMI; FMF. PMA / 510(K)#: K941562; K161170. 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 A SCALE MARKING ISSUE OCCURRED BEFORE USE WITH A SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SCALE MISSING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656806 SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE;  PISTON SYRINGE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8052070 30382903057895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other