BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRASAFE¿ PLUS X100L

    MDR report key: 7890268 · Received September 19, 2018

    Report

    Report Number
    3001741852-2018-00017
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 29, 2018
    Report Date
    October 1, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLE PROVIDED FOR EVALUATION. THE BATCH WAS PRODUCED BY BD SUPPLIER, THEREFORE NO BATCH RECORD IS AVAILABLE FOR REVIEW BY THE BD TEAM LEADER. BATCH RELEASE DOCUMENTS WERE CHECKED AND NO ABNORMALITIES WERE OBSERVED. THE BATCH WAS RELEASED ACCORDING TO THE SUPPLIER AGREEMENTS AND MET ACCEPTANCE CRITERIA WHEN SHIPPED. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY THE CUSTOMER BUT NOT CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS. A FULL ROOT CAUSE ANALYSIS COULD NOT BE CONDUCTED WITH THE AVAILABLE INFORMATION AND IS CLOSED WITHOUT A CONCLUSION. IT HAS ALSO BEEN CONCLUDED BY THE CUSTOMER THAT UPON EVALUATION OF THE PLUNGER ROD NO ABNORMALITIES WERE DETECTED AND INJECTION COULD BE DELIVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRASAFE¿ PLUS X100L SYRINGE HAD DIFFICULT PLUNGER MOVEMENT AND WOULDN'T DISPENSE MEDICATION. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9233075, MEDICAL DEVICE EXPIRATION DATE: 2020-05-02, DEVICE MANUFACTURE DATE: 2016-05-13. MEDICAL DEVICE LOT #: 9368909, MEDICAL DEVICE EXPIRATION DATE: 2021-02-14, DEVICE MANUFACTURE DATE: 2017-02-20. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ULTRASAFE¿ PLUS X100L SYRINGE HAD DIFFICULT PLUNGER MOVEMENT AND WOULDN'T DISPENSE MEDICATION. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730715 BD ULTRASAFE¿ PLUS X100L SYRINGE FMF BECTON DICKINSON SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other