BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 9261385 · Received October 31, 2019

    Report

    Report Number
    8041187-2019-00875
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 11, 2019
    Report Date
    November 19, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057871
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO WAS RECEIVED FOR INVESTIGATION. THERE ARE NO ECLIPSE PRODUCT IN THE PHOTO, ONLY THE SHELF LABEL WAS SHOWN. HENCE UNABLE TO OBSERVE THE SAFETY SHIELD BROKE OFF DEFECT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. CONCLUSION: THE REPORTED DEFECT CANNOT BE CONFIRMED AS ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED IF THE SAMPLE IS RETURNED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ECLIPSE¿ NEEDLE SAFETY SHIELD DID NOT ENGAGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305787, BATCH NO.: 8082132. IT WAS REPORTED THE SAFETY SHIELD DID NOT ENGAGE THE NEEDLE BECAUSE IT HAD FALLEN OFF. PER EMAIL: CUSTOMER HAS BROUGHT OUR ATTENTION TO AN ISSUE WITH BD ECLIPSE SAFETY NEEDLES. TWICE, WHILE A NURSE ACTIVATED THE SAFETY FEATURE, (USING THE ONE-HANDED TECHNIQUE) THE PINK SAFETY SHIELD CAME OFF AND DID NOT ENGAGE THE NEEDLE. WITH AN ABUNDANCE OF CAUTION WE ARE ADVISING THAT YOU NOT USE THESE NEEDLES UNTIL WE HAVE DETERMINED THE CAUSE OF THE PROBLEM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. PMA/510(K)#: K980987(SYRINGE); K161170 (NEEDLE). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ECLIPSE¿ NEEDLE SAFETY SHIELD DID NOT ENGAGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305787, BATCH NO.: 8082132. IT WAS REPORTED THE SAFETY SHIELD DID NOT ENGAGE THE NEEDLE BECAUSE IT HAD FALLEN OFF. PER EMAIL: CUSTOMER HAS BROUGHT OUR ATTENTION TO AN ISSUE WITH BD ECLIPSE SAFETY NEEDLES. TWICE, WHILE A NURSE ACTIVATED THE SAFETY FEATURE, (USING THE ONE-HANDED TECHNIQUE) THE PINK SAFETY SHIELD CAME OFF AND DID NOT ENGAGE THE NEEDLE. WITH AN ABUNDANCE OF CAUTION WE ARE ADVISING THAT YOU NOT USE THESE NEEDLES UNTIL WE HAVE DETERMINED THE CAUSE OF THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053257 BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8082132 30382903057871

    Patients

    Seq Age Sex Outcome Treatment
    1 Other