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: 6760478 · Received August 2, 2017

    Report

    Report Number
    1024879-2017-00101
    Event Type
    Injury
    Date Received
    August 2, 2017
    Date of Event
    May 24, 2017
    Report Date
    February 15, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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. CONCLUSION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED THE FOLLOWING LOT NUMBERS FOR THESE INCIDENTS: 7090796, 5217797, 7118700, 6356988, 7111774, 7095526. HOWEVER ONLY LOT NUMBERS 7111774 AND 7095526 EXIST FOR THE REPORTED CATALOG NUMBER 368607. THE INFORMATION FOR THESE TWO POTENTIAL LOT NUMBERS IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7111774, MEDICAL DEVICE EXPIRATION DATE: 4/30/2022, DEVICE MANUFACTURE DATE: 4/21/2017. MEDICAL DEVICE LOT #: 7095526, MEDICAL DEVICE EXPIRATION DATE: 4/30/2022, DEVICE MANUFACTURE DATE: 4/5/2017. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AT, "TWO DIFFERENT COLLECTION SITES USING DIFFERENT NEEDLE SETS: REUSABLE (NEEDLE HOLDER) AND SINGLE USE," TWO PATIENTS DEVELOPED INFECTIONS AFTER VENI-PUNCTURE PROCEDURES WITH A 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER. PATIENTS WERE PLACED ON ANTIBIOTICS. THE SPECIFIC DETAILS FOR EACH PATIENT/INCIDENT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542631 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other