BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SLIP-TIP SYRINGE

    MDR report key: 9916739 · Received April 2, 2020

    Report

    Report Number
    1213809-2020-00236
    Event Type
    Malfunction
    Date Received
    April 2, 2020
    Date of Event
    March 13, 2020
    Report Date
    April 13, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER ADDITIONAL REVIEW, THIS REPORT IS A DUPLICATE REPORT OF MFR # 1213809-2020-00225. THIS EVENT HAS BEEN OVER-REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A GREASE-LIKE SUBSTANCE WAS FOUND ON THE BD¿ SLIP-TIP SYRINGE STOPPER. LOT#'S 0022940, 0002168, AND 9322411 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER CUSTOMER THE BLACK PORTION OF SYRINGE HAS GREASE LIKE SUBSTANCE ON IT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 #: 0022940, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-01-22, MEDICAL DEVICE LOT #: 0002168, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-01-02, MEDICAL DEVICE LOT #: 9322411, MEDICAL DEVICE EXPIRATION DATE: 2024-11-30, DEVICE MANUFACTURE DATE: 2019-11-18. THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) USA HAS BEEN USED AS A DEFAULT. 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 A GREASE-LIKE SUBSTANCE WAS FOUND ON THE BD¿ SLIP-TIP SYRINGE STOPPER. LOT#'S 0022940, 0002168, AND 9322411 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PER CUSTOMER THE BLACK PORTION OF SYRINGE HAS GREASE LIKE SUBSTANCE ON IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382617 BD SLIP-TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other