BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN FAST FLASH 18G 25MM

    MDR report key: 24843480 · Received April 10, 2026

    Report

    Report Number
    3006846316-2026-00001
    Event Type
    Malfunction
    Date Received
    April 10, 2026
    Date of Event
    January 1, 2026
    Report Date
    April 10, 2026
    Manufacturer
    DELTA MED SPA
    Product Code
    FOZ
    PMA / PMN Number
    K200373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUBJECT: REPORT (B)(4) RECEIVED BY US AGENT MR LIEBERMAN (DELTA MED'S US AGENT) ON MARCH 17, 2025, INVOLVING A DELTAVEN G18 25MM LOT 11T15109 REF (B)(4) WHICH DESCRIBED BLOOD LEAKAGE FROM THE ONE-WAY VALVE WHILE RETRACTING THE NEEDLE. FOLLOWING THAT PROBLEM ANOTHER IV CATHETER HAS TO BE PLACED. THE ONE-WAY VALVE REPORTED HAS BEEN IDENTIFIED BY DELTA MED AS THE SILICONE RUBBER SEPTUM THAT ALLOWS NEEDLE ACCESS INTO THE CATHETER. FROM THE REPORT, IT APPEARS THAT THE DEVICE INVOLVED IN THE INCIDENT THAT OCCURRED IN JANUARY 2026 IS NOT AVAILABLE. A REVIEW OF THE INTERNAL DOCUMENTATION SHOWS THAT NO SIMILAR INCIDENTS HAVE PREVIOUSLY OCCURRED FOR THE SAME STERILE PRODUCT LOT. FOLLOWING THE ABOVE-MENTIONED REPORT, DOCUMENTATION RELATED TO THE BATCH RECORD OF THE LOT UNDER COMPLAINT WAS PREPARED, SPECIFICALLY CONCERNING THE PERFORABLE SEPTUM CONSIDERED RESPONSIBLE FOR THE LEAKAGE. BELOW IS THE DOCUMENTATION ANALYZED: 1 STERILIZATION ORDER NO. 19011 DATED 07/07/21 FOR LOT 11T15109, CARRIED OUT ON 09/07/21 WITH STERILIZATION LOT NO. 210709A13, RELEASED ON 16/07/21. DOCUMENT REVIEW DID NOT REVEAL ANY ISSUES WITH STERILIZATION PARAMETERS; IN PARTICULAR, TEMPERATURE (PREHEATING, STERILIZATION, DEGASSING), RELATIVE HUMIDITY, GAS MIXTURE QUANTITY INTRODUCED INTO THE CHAMBER, AND CYCLE DURATION ALL COMPLIED WITH PREDEFINED AND VALIDATED LIMITS (ANNEX A) 2 INCOMING RAW MATERIALS: ACCORDING TO OUR INTERNAL TRACEABILITY TWO LOTS OF PERFORABLE SEPTA USED IN THE PRODUCTION OF THE ABOVE-MENTIONED CATHETER (LOT 10075) WERE IDENTIFIED: ·INTERNAL LOT 00208-01202, CODE 00040016, CONSISTING OF (B)(4) UNITS RECEIVED ON 03/03/2021, COMPLIANT WITH INCOMING RAW MATERIAL ACCEPTANCE CHECKS. ·INTERNAL LOT 10094-01201, CODE 00040016, CONSISTING OF (B)(4) UNITS RECEIVED ON 19/03/2021, COMPLIANT WITH INCOMING RAW MATERIAL ACCEPTANCE CHECKS. PRODUCTION ORDER 10075 RELATING TO LOT 00000-10075, CODE 10071711, DESCRIPTION: CAT SM SC SIC PUR 18G 25MM 2.4MM, WITH (B)(4) UNITS PRODUCED USING TWO LOTS OF PERFORABLE SEPTA ABOVE MENTIONED: 00208-01202 AND 10094-01201 (ANNEX C) IN ATTACHMENTS B1 AND B2, WE PROVIDE THE INSPECTION REPORTS FOR THE PIERCEABLE SEPTUM. THE INSPECTIONS PERFORMED ON THESE TWO LOTS OF SEPTUM ARE VISUAL (PRESENCE OF BURRS, DIRT, FOREIGN BODIES, DEFORMATION, AND DISCOLORATION), DIMENSIONAL (OVERALL LENGTH), AND FUNCTIONAL (LEAK TEST AT 3 BAR). FROM A TRACEABILITY PERSPECTIVE, WE PROVIDE THE DOCUMENTS LINKING BATCH 00000-10075 TO BATCH 11T15109 (THE REPORTED FINISHED PRODUCT BATCH): 3 PRODUCTION ORDER 15109 RELATING TO LOT 00000-15109, CODE 10731411, DESCRIPTION: SC1 SIC SM 18G X 25MM PUR 2.4 X 100, WITH (B)(4) UNITS MANUFACTURED USING CATHETER LOT 10075 (ANNEX D) 4 PACKAGING ORDER FOR LOT 11T15109, CODE 3845773, DESCRIPTION: DELTAVEN USA FF 18G 25MM C, WITH (B)(4) UNITS PRODUCED AND PACKAGED USING LOT 15109 (ANNEX E). FROM THE ANALYSIS OF THE BATCH RECORD DATA EXAMINED, NO ISSUES HAVE EMERGED THAT COULD EXPLAIN A MALFUNCTION OF THE DEVICE. THE FACT THAT THE CATHETER SUBJECT TO THE REPORT IS CLOSE TO ITS EXPIRATION DATE (JUST OVER ONE MONTH REMAINING) COULD SUGGEST THAT, DUE TO IMPROPER STORAGE CONDITIONS[?]SUCH AS ELEVATED TEMPERATURE OR HUMIDITY[?]THE SILICONE SEPTUM MAY HAVE DEGRADED OVER TIME DUE TO CONTINUOUS ADAPTATION TO THE INSERTED NEEDLE, RESULTING IN THE REPORTED LEAKAGE.

    Description of Event or Problem · 0

    DESCRIBE THE EVENT OR PROBLEM: AFTER INSERTING THE IV AND RETRACTING THE NEEDLE, THE ONE-WAY VALVE WAS LEAKING WHEN FLUSHED. THE NURSE WAS UNABLE TO USE THE CATHETER AND REQUIRED ANOTHER IV TO BE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906495 DELTAVEN FAST FLASH 18G 25MM I.V. CATHETRS WITH CLOSED SYSTEM FOZ DELTA MED SPA 3845773 11T15109

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other