BEUDAMED
    FDA Adverse Event Injury Summary report: N

    30 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 5648132 · Received May 11, 2016

    Report

    Report Number
    8041187-2016-00032
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    April 26, 2016
    Report Date
    June 29, 2016
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SECOND CATALOG NUMBER AND TWO POTENTIAL LOT NUMBERS WERE PROVIDED AS SAMPLES FOR INVESTIGATION. THE INFORMATION FOR THESE LOT NUMBERS IS AS FOLLOWS: MEDICAL DEVICE CATALOG #: 305757, MEDICAL DEVICE LOT #: 5231206, MEDICAL DEVICE EXPIRATION DATE: 08/31/2020, MEDICAL DEVICE MANUFACTURE DATE: 08/19/2015. MEDICAL DEVICE CATALOG #: 305757, MEDICAL DEVICE LOT #: 5261112, MEDICAL DEVICE EXPIRATION DATE: 09/30/2020, MEDICAL DEVICE MANUFACTURE DATE: 09/18/2015. DEVICE EVALUATION: RESULTS: THE CUSTOMER DID NOT RETURN THE ACTUAL SAMPLES NOR SAMPLES FROM THE SAME LOT. HOWEVER, THE CUSTOMER RETURNED REPRESENTATIVE (SIX- 3 FROM EACH LOT) SAMPLES FOR BD ECLIPSE¿ 30G ½ NEEDLE IN SEALED BLISTERPACK (CAT#305757. LOT# 5231206 AND 5261112) WHICH ARE SIMILAR PRODUCT TO 305778. TWO SAMPLES (ONE FROM EACH LOT) WERE TESTED AND NO ISSUES WERE OBSERVED. THE SAFETY MECHANISMS ACTIVATED PROPERLY. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE LOT NUMBERS 5231206 AND 5261112. A MANUFACTURING REVIEW REVEALED THAT THE REPORTED DEFECT WAS NOT AFFECTED BY PM, CALIBRATION, OR EQUIPMENT. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. HOWEVER, AS PREVIOUSLY REPORTED, CAPA (B)(4) WAS INITIATED TO ADDRESS SAFETY SHIELD DISENGAGEMENT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH IT WAS INITIALLY REPORTED THAT A SAMPLE WAS AVAILABLE, A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER FOR THIS INCIDENT WAS NOT PROVIDED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. HOWEVER, CAPA (B)(4) HAS BEEN OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A NURSE HAD USED A 30 G X 1/2 IN. BD ECLIPSE 1 ML BD LUER-LOK SYRINGE WITH DETACHABLE NEEDLE, SHE ACTIVATED THE SAFETY MECHANISM, HEARD A CLICK AND THOUGHT THE NEEDLE WAS COVERED; HOWEVER, THE NEEDLE WAS NOT COVERED BY THE SAFETY MECHANISM AND THE NURSE OBTAINED A NEEDLE STICK INJURY FROM THE USED DEVICE. THE NURSE RECEIVED POST EXPOSURE LAB WORK, RESULTS OF WHICH ARE UNAVAILABLE. NO ADDITIONAL MEDICAL INTERVENTIONS OR PROPHYLAXIS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302459 30 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE SYRINGE AND NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention