BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASEMBLED NEEDLE ECLIPSE 22X1-1/4 WSS

    MDR report key: 10557408 · Received September 18, 2020

    Report

    Report Number
    3002682307-2020-00283
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 30, 2020
    Report Date
    November 16, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 0082338 AND 0070661. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE AND PHYSICAL SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THREE ECLIPSE NEEDLES WERE PROVIDED. THROUGH EXAMINATION OF THE SAMPLES, TWO OF THE NEEDLES DID NOT HAVE THE SAFETY SHIELD ASSEMBLED AND THE REMAINING NEEDLE DID HAVE THE SAFETY SHIELD ASSEMBLED. THE TWO SAMPLES MISSING SHIELDS WERE EVALUATED THROUGH A HUB-SHIELD FITTING TEST AND SHIELDS WERE ABLE TO BE ASSEMBLED TO THE PRODUCT. HUB AND SHIELD FITTING VALUES ARE TESTED DURING THE INSPECTION OF THE PRODUCT. IF THE FITTINGS ARE TOO HIGH, THE SHIELD CANNOT BE REMOVED FROM THE NEEDLE AND IF THE FITTINGS ARE TOO LOW, THE SHIELD IS AT RISK OF FALLING OFF DURING HANDLING OF THE PRODUCT. IT IS POSSIBLE THAT THE NON-ASSEMBLED PRODUCT RESULTED FROM AN ERROR DURING THE ASSEMBLY PROCESS. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH A LOW CHANGE OF RECURRENCE. IN RESPONSE TO THIS ISSUE, AN ALERT HAS BEEN COMMUNICATED TO THE MANUFACTURING FACILITY PERSONNEL TO RAISE AWARENESS FOR THIS POTENTIAL DEFECT ON THE PRODUCTION FLOOR. OUR QUALITY TEAM WILL CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ASSEMBLED NEEDLE ECLIPSE 22X1-1/4 WSS BROKE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR SAFETY NEEDLE 5 ML 1-NEEDLE WITHOUT COVERS. 2- CAPS WITHOUT NEEDLE. 3- BROKEN NEEDLE.

    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 #: 0082338, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 2020-03-22, MEDICAL DEVICE LOT #: 0070661, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 2020-03-10. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ASSEMBLED NEEDLE ECLIPSE 22 X 1-1/4 WSS BROKE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOR SAFETY NEEDLE 5 ML NEEDLE WITHOUT COVERS. CAPS WITHOUT NEEDLE. BROKEN NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022020 ASEMBLED NEEDLE ECLIPSE 22X1-1/4 WSS NEEDLE FMI BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other