BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JELCO

    MDR report key: 12481784 · Received September 16, 2021

    Report

    Report Number
    3012307300-2021-09411
    Event Type
    Injury
    Date Received
    September 16, 2021
    Date of Event
    April 15, 2021
    Report Date
    November 10, 2021
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FOZ
    UDI-DI
    10351688071187
    PMA / PMN Number
    K990236
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE UNIT WAS RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD NOT BE DUPLICATED. DHR REVIEW WAS DONE, NONCONFORMANCE DATA IDENTIFIED ONE IN-PROCESS NONCONFORMANCE, HOWEVER, THE NONCONFORMING PRODUCT WAS FROM TOTES NOT INCLUDED IN LOT # 4061730 AND WAS SCRAPPED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PERIPHERAL INTRAVENOUS CATHETERS (PIVC) JELCO SAFETY PROTECTIV PLUS CATHETER, BLOOD LEAKAGE WAS NOTED AT THE PUNCTURE POINT AND PATIENT EXPERIENCED PAIN DURING VEIN PATENCY TEST. IT WAS ALSO REPORTED THAT THE CATHETER WAS REMOVED BUT A TIP OF PLASTIC TUBING WAS REMAINING STUCK IN THE ARM. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378323 JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM FOZ SMITHS MEDICAL ASD, INC. 306001 4061730 10351688071187

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown