BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION

    MDR report key: 8061388 · Received November 12, 2018

    Report

    Report Number
    3002682307-2018-00277
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    October 24, 2018
    Report Date
    November 15, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903058921
    PMA / PMN Number
    K100209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RETURNED FOR EVALUATION. DHR REVIEW: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. NEEDLES WERE PACKED IN MACHINE 2101 (JANUARY 28-29TH, 2018) DURING WHICH 46 VISUAL INSPECTIONS WERE CARRIED OUT WITH 0 DEFECTS NOTED. NEEDLES WERE ASSEMBLED IN MACHINE 4261-4249 AND COME FROM TWO BATCHES: ¿ #8024908 (JANUARY 27-29TH, 2018) DURING WHICH 84 VISUAL INSPECTIONS O WERE PERFORMED WITH ZERO DEFECTS NOTED. ¿ #7338902 (DECEMBER 05-07TH, 2018) DURING WHICH 84¡5 VISUAL INSPECTIONS O WERE PERFORMED WITH ZERO DEFECTS NOTED. RESEARCH HAS NOT FOUND ANY ISSUES OR ABNORMALITY IN INJECTED HUB BATCHES #7325868, #7338684, #8022782 AND #8015777 (MOULD MACHINE #3590 ¿ NOVEMBER 2017 - JANUARY 2018). EVERY SINGLE INJECTED HUB BATCH, AT THE BEGINNING, A LEAKAGE TEST IS PERFORMED AND ALL RESULTS WERE WITHIN SPECIFICATION. CANNULA BATCHES #7270413 AND #7292499. BASED ON ABOVE INFORMATION, WITHOUT AFFECTED SAMPLE AND SINCE WE DO NOT KNOWN IF INSTRUCTIONS WERE CORRECTLY FOLLOWED, WE COULD NOT IDENTIFIED ANY POSSIBLE ROOT CAUSE RELATED NEEDLE MANUFACTURING PROCESS AT THIS TIME. SMARTSLIP TECHNOLOGY (TM) HAS BEEN INTRODUCED TO HELP TO ENSURE THAT A SECURE CONNECTION IS MADE WITH LUER SLIP SYRINGES. IT HAS BEEN DESIGNED TO REDUCE THE RISK OF NEEDLE DISENGAGEMENT FROM LUER SLIP SYRINGES, WHICH ARE THE MOST COMMON SYRINGE DESIGN (IN EUROPE). MOREOVER, OUR NEEDLES ARE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS AND COMPLIES WITH INTERNATIONAL STANDARD ISO 594/1 "CONICAL FITTINGS WITH A 6% (LUER) TAPER FOR SYRINGES, NEEDLES AND CERTAIN OTHER MEDICAL EQUIPMENT¿. THE LEAKAGE ISSUE COULD PROBABLY BE BECAUSE OF A DEFECTIVE LUER DIMENSIONS OR ANY DAMAGE IN THE SYRINGE TIP, BUT IT COULD BE ALSO RELATED WITH THE HANDLING OF THE PRODUCT AS SOME INSUFFICIENT ADJUSTMENT BETWEEN OF THE DEVICES BY THE END USER. A DEFINITIVE ROOT CAUSE IS NOT POSSIBLE TO DETERMINE. IT WAS DETERMINED THAT NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION LEAKED FROM BASE OF THE NEEDLE DURING INJECTION. THERE WAS NO REPORT OF EXPOSURE TO THE MUCOSAL MEMBRANE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION LEAKED FROM BASE OF THE NEEDLE DURING INJECTION. THERE WAS NO REPORT OF EXPOSURE TO THE MUCOSAL MEMBRANE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902197 BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 1801011 00382903058921

    Patients

    Seq Age Sex Outcome Treatment
    1 Other