BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE, 10ML SALINE IN 10ML

    MDR report key: 18951547 · Received March 21, 2024

    Report

    Report Number
    2027791-2024-00050
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    October 18, 2019
    Report Date
    March 19, 2024
    Manufacturer
    MEDLINE EXCELSIOR
    Product Code
    NGT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT SYRINGES WERE RECEIVED DAMAGED DUE TO OPEN OVERWRAP. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE. A PHOTO WAS PROVIDED FOR REVIEW, HOWEVER, NO SYRINGE DAMAGE WAS OBSERVED. NO PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION. ONE (1) BOX OF RETAINED SAMPLES FOR EACH REPORTED PRODUCT LOT WAS EVALUATED TO DETERMINE IF ANY OF THE SYRINGES FROM EITHER LOTS SHOWED OPEN OR DAMAGED OVERWRAP. TWO (2) SYRINGES FROM LOT 3133549 SHOWED PARTIALLY TORN OVERWRAP NEAR THE SEAL. IN AN ABUNDANCE OF CAUTION, AND IN RESPONSE TO AN FDA 483 ISSUED FOR CFN 1417592 ON 22-JAN-2024, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED. ADDITIONAL PRODUCT LOT REPORTED = 3133549.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGES WERE RECEIVED DAMAGED DUE TO OPEN OVERWRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531972 SYRINGE, 10ML SALINE IN 10ML NGT MEDLINE EXCELSIOR 513576 3133324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other