BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ECLIPSE¿

    MDR report key: 8506921 · Received April 11, 2019

    Report

    Report Number
    9617032-2019-00435
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 18, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR A SCREW IN THE BARREL OF THE SYRINGE WAS OBSERVED WITH THE INCIDENT LOT . ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED OBSERVED A SCREW IN THE BARREL OF ONE OF THREE RETURNED SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR A SCREW IN THE BARREL OF THE SYRINGE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF ONE OF THE RETURNED CUSTOMER SAMPLES WAS CONDUCTED AND A SCREW IN THE BARREL OF THE SYRINGE WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. 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 BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WAS A SCREW INSIDE SYRINGE PISTON WITH A BD PRESET¿ ECLIPSE¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: THERE WAS FOUND A SCREW INSIDE THE SYRINGE PISTON.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7290565; MEDICAL DEVICE EXPIRATION DATE: 2019-10-31; DEVICE MANUFACTURE DATE: 2017-10-17; MEDICAL DEVICE LOT #: 9022806; MEDICAL DEVICE EXPIRATION DATE: 2021-01-31; DEVICE MANUFACTURE DATE: 2019-01-22 . " INITIAL REPORTER PHONE #: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WAS A SCREW INSIDE SYRINGE PISTON WITH A BD PRESET¿ ECLIPSE¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THERE WAS FOUND A SCREW INSIDE THE SYRINGE PISTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298423 BD PRESET¿ ECLIPSE¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other