BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL

    MDR report key: 18624264 · Received February 1, 2024

    Report

    Report Number
    1911916-2024-00051
    Event Type
    Malfunction
    Date Received
    February 1, 2024
    Date of Event
    January 25, 2024
    Report Date
    February 2, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) : INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED .

    Additional Manufacturer Narrative · 0

    PR (B)(4) - FOLLOW UP MDR FOR CORRECTION / DUPLICATE. FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THIS WAS A DUPLICATE COMPLAINT TO PR (B)(4) H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    MATERIALS#: 306547 BATCH#: 3090897 IT WAS REPORTED BY THE CUSTOMER THAT BLOOD SPRAY FROM INSIDE THE SYRINGE (LEAKING AROUND PLUNGER). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. # OF OCCURRENCES: 2 DATE OF OCCURRENCE(S): ON (B)(6) 2024 DATE COMPLAINT RECEIVED FROM CUSTOMER: ON (B)(6) 2024 PRODUCT CODE: 306547 PICTURES OF DEVICE? SEE ABOVE LOT NUMBER: 3090897 WITH EXPIRATION DATE OF 2026/03/31 DETAILED DESCRIPTION: UPON VERIFICATION OF HD CATHETER PATENCY THE NURSING STAFF EXPERIENCED A BLOOD SPRAY FROM INSIDE THE SYRINGE (LEAKING AROUND PLUNGER). THE PATIENT WAS ALSO SOILED WITH BLOOD. QUESTIONABLE CONTAMINATION OF BLOOD? BLOOD NOT RETURNED TO PATIENT. SAMPLE SAVED? NO BIOHAZARD SAMPLE? NO WHAT WAS THE PATIENT OUTCOME? SOILED CLOTHING AND SLIGHT BLOOD LOSS WAS THERE ANY DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THIS EVENT? SLIGHT DELAY WHAT PROCEDURE WAS BEING PERFORMED? VERIFYING THE PATENCY OF A HEMODIALYSIS CATHETER WHAT MEDICATION WAS USED IN THE PROCEDURE? NONE WAS THERE ANY MEDICAL INTERVENTION DUE TO THIS EVENT? NO HAS THIS EVENT RESULTED IN A SERIOUS INJURY TO THE PATIENT OR MEDICAL STAFF? NO HAS THIS EVENT RESULTED IN A CHANGE DURING TREATMENT? NO, OTHER SYRINGES FROM OTHER LOT NUMBERS WERE AVAILABLE HAS THIS EVENT RESULTED IN EXPOSURE OF MEDICAL STAFF TO THE BLOOD OF THE PATIENT? YES IF SO, WAS MEDICAL INTERVENTION OFFERED OR PROVIDED IN THE FORM OF MEDICATION OR SCREENING? NO OPEN WOUNDS OR MUCOUS MEMBRANES WERE AFFECTED SO CLEANING WITH AN ASEPTIC WAS SATISFACTORY. HAS THIS EVENT RESULTED IN A NEEDLE STICK?NO

    Description of Event or Problem · 0

    DUPLICATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073208 SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL SALINE, VASCULAR ACCESS FLUSH NGT BECTON DICKINSON 3090897 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown