BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 8065380 · Received November 13, 2018

    Report

    Report Number
    3002682307-2018-00285
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 13, 2018
    Report Date
    December 26, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903057603
    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: BD HAS BEEN PROVIDED WITH 105 PACKED SAMPLES OF LOT 1501003. 30 UNITS WERE TESTED FOR ENGAGEMENT FORCE WITH CORRECT RESULTS. SEVERAL BD ECLIPSE NEEDLES WERE ASSEMBLED ONTO EMERALD SYRINGES AND LEAKAGE TEST WAS PERFORMED WITH NO ABNORMALITIES OR ISSUES OBSERVED. DHR REVIEW: PRODUCTION AND INSPECTION RECORDS REVIEW ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. NEEDLES WERE PACKED IN MACHINE 2105 (JANUARY 12-14TH, 2015) DURING WHICH 65 VISUAL INSPECTIONS WERE CARRIED OUT WITH 0 DEFECTS NOTED. NEEDLES WERE ASSEMBLED IN MACHINE 4249-4261 AND COME FROM TWO ASSEMBLED BATCHES: -#5007433 (JANUARY 9-14TH, 2015) DURING WHICH 190 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. -#4275172 (OCTOBER 4-16TH, 2014) DURING WHICH 245 VISUAL INSPECTIONS OF 25 UNITS EACH WERE PERFORMED WITH ZERO DEFECTS NOTED. RESEARCH HAS NOT FOUND ANY ISSUES OR ABNORMALITY IN INJECTED HUB BATCHES #4135356, #4142197, #4185033, #4128410, #4281065, #4290053, #4303178, #7274216, #4182073, #4119040, #4104009, #4351499, #4094113, #4115192, #4311048, #4274216, #4328294, #4349318. 1QN (#5767) WAS FOUND RELATED IMPROPER MOLDED IN INJECTED HUB BATCH #4317110, BUT THIS WOULD NOT AFFECT WHETHER OR NOT THE REPORTED ISSUE. CANNULA BATCHES: #4196202 AND #4287049. BASED ON ABOVE RESULTS AND SINCE BD DOES NOT KNOW IF INSTRUCTIONS WERE CORRECTLY FOLLOWED, BD COULD NOT IDENTIFIED ANY POSSIBLE ROOT CAUSE RELATED NEEDLE MANUFACTURING PROCESS. SINCE COMPLAINT IS NOT POSSIBLE TO CONFIRM AND THIS IS THE FIRST TIME COMPLAINED RECEIVED FOR THIS ISSUE AND THIS, IT WAS DETERMINE THAT NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD ECLIPSE¿ NEEDLE THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF 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 WITH THE USE OF THE BD ECLIPSE¿ NEEDLE THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905390 BD ECLIPSE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 1501003 00382903057603

    Patients

    Seq Age Sex Outcome Treatment
    1 Other