BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNSPECIFIED BD ECLIPSE¿ NEEDLE

    MDR report key: 6329682 · Received February 14, 2017

    Report

    Report Number
    8041187-2017-00012
    Event Type
    Injury
    Date Received
    February 14, 2017
    Date of Event
    January 16, 2017
    Report Date
    March 14, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE ACTUAL LOT NUMBER USED IN THIS INCIDENT REMAINS UNKNOWN. THE CUSTOMER RETURNED SAMPLES FOR THE ADDITIONAL POTENTIAL LOT NUMBERS FOR PREVIOUSLY REPORTED CATALOG 305759: LOT 4356354, DEVICE EXPIRATION DATE 12/31/2019, DEVICE MANUFACTURE DATE 12/22/2014. LOT 4356266, DEVICE EXPIRATION DATE 12/31/2019, DEVICE MANUFACTURE DATE 12/22/2014. DEVICE EVALUATION: A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBERS 4356354 AND 4356266. THE COMPLAINT HANDLING LAB RECEIVED 100 SEALED SAMPLES OF BD NEEDLE ECLIPSE 25X5/8 CAT# 305759 LOT# 4356354. THIRTY (30) SAMPLES WERE RANDOMLY SELECTED AND ACTIVATED ACCORDING TO THE STEPS IN THE IFU. NO SAFETY MECHANISMS BROKE OFF. ONE (1) SAMPLE OF THE 30 TESTED SAMPLES HAD A FALSE CLICK (DOUBLE CLICK) OBSERVED. THE COMPLAINT HANDLING LAB RECEIVED 100 SEALED SAMPLES OF BD NEEDLE ECLIPSE 25X5/8 CAT# 305759 LOT# 4356266. THIRTY (30) SAMPLES WERE RANDOMLY SELECTED AND ACTIVATED ACCORDING TO THE STEPS IN THE IFU. NO SAFETY MECHANISMS BROKE OFF. CONCLUSION - BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. OF NOTE, CAPA (B)(4) HAVE BEEN OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. THIS PRODUCT HAS A FIELD ACTION NOTIFICATION, (B)(4).

    Additional Manufacturer Narrative · 1

    SECTION D, SUSPECT MEDICAL DEVICE; SECTION H, DEVICE MANUFACTURE DATE - THE CUSTOMER PROVIDED BD CATALOG 305759 AND LOT 6140350 AS THE DEVICE USED IN THIS INCIDENT. HOWEVER, THIS PROVIDED LOT NUMBER IS FOR A DIFFERENT BD CATALOG NUMBER THAN REPORTED. INFORMATION FOR THE POTENTIAL DEVICES INVOLVED IN THIS INCIDENT ARE AS FOLLOWS: MEDICAL DEVICE BRAND NAME: 25 G X 1 IN. BD ECLIPSE¿ NEEDLE. MEDICAL DEVICE CATALOG # 305761. MEDICAL DEVICE LOT # 6140350. MEDICAL DEVICE EXPIRATION DATE: 05/31/2021. DEVICE MANUFACTURE DATE: 05/19/2016. (B)(4). MEDICAL DEVICE BRAND NAME: 25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE. MEDICAL DEVICE CATALOG # 305759. MEDICAL DEVICE LOT # UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN AS THE LOT NUMBER IS UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN AS THE LOT NUMBER IS UNKNOWN. (B)(4). DEVICE EVALUATION: A SAMPLE IS AVAILABLE FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE USER WAS GIVING AN HIB VACCINE TO A (B)(6) OLD MALE, THE PINK SAFETY SHIELD SLIPPED OFF THE SUSPECT DEVICE. THIS CAUSED THE NEEDLE TO PUNCTURE THE USER'S FINGER WHILE SHE WAS INJECTING THE VACCINE. BOTH THE USER AND INFANT HAD LAB WORK BUT NO FURTHER MEDICAL ATTENTION WAS REQUIRED AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111074 UNSPECIFIED BD ECLIPSE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention