BEUDAMED
    FDA Adverse Event Injury Summary report: N

    21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 6753115 · Received July 29, 2017

    Report

    Report Number
    1024879-2017-00099
    Event Type
    Injury
    Date Received
    July 29, 2017
    Date of Event
    May 16, 2017
    Report Date
    February 15, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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 NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THERE WERE POTENTIALLY TWO LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7095526, EXPIRATION DATE: 04/30/2022, MANUFACTURE DATE: APRIL-2017. MEDICAL DEVICE LOT #: 7111774, EXPIRATION DATE: 04/30/2022, MANUFACTURE DATE: APRIL-2017. INVESTIGATION SUMMARY BD RECEIVED SAMPLES FROM TWO POTENTIAL LOTS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE LOT NUMBER INVOLVED IN THESE INCIDENTS COULD NOT BE CONFIRMED BY THE CUSTOMER; THEREFORE, ALL POTENTIAL LOT NUMBERS INDICATED BY THE CUSTOMER WERE INVESTIGATED. ALL CUSTOMER SAMPLES WERE EVALUATED FOR UNIT LABELING BREACH, AND ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT NUMBER AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. PRODUCT WAS STERILIZED IN ACCORDANCE WITH PRODUCT SPECIFICATION. NO FURTHER STERILITY TESTING COULD BE CONDUCTED ON THE RETURNED SAMPLES AS THE PRODUCT HAS BEEN STERILIZED. INVESTIGATION CONCLUSION BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE WAS NOT OBSERVED. UPON INSPECTION OF THE CUSTOMER SAMPLES, ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ROOT CAUSE DESCRIPTION BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD PAS BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE DATE OF EVENT WAS REPORTED AS (B)(6) 2017. THE ACTUAL DATE OF EVENT WAS (B)(6) 2017. THE DATE RECEIVED BY MANUFACTURER WAS REPORTED AS 07/05/2017. THE ACTUAL DATE RECEIVED BY MANUFACTURER WAS 06/22/2017.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO PATIENTS DEVELOPED INFECTIONS POSSIBLY RELATED TO VENI-PUNCTURE PROCEDURES WHILE USING A 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER. TWO DIFFERENT COLLECTION SITES AND NEEDLE SETS WERE USED; BOTH REUSABLE AND SINGLE USE. THE TWO PATIENTS WERE PLACED ON ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533187 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention