BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN FAST FLASH 20G 32MM

    MDR report key: 25012321 · Received April 28, 2026

    Report

    Report Number
    3006846316-2026-00002
    Event Type
    Malfunction
    Date Received
    April 28, 2026
    Date of Event
    March 1, 2026
    Report Date
    April 27, 2026
    Manufacturer
    DELTA MED SPA
    Product Code
    FOZ
    UDI-DI
    08032248383678
    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 FROM FDA UF/IMPORTER REPORT # (B)(4) RECEIVED FROM FDA ON 07/04/26 INVOLVING A DELTAVEN FF G20 32 MM LOT 11T45107 REF (B)(4). THE REASON OF THE REPORT IS AS FOLLOW: WHEN THE PERIPHERAL IV WAS INSERTED IN THE PATIENT'S VEIN, BLOOD LEAKED BACK FROM THE PORT. SITE WAS CLEANED AND BLEEDING DID NOT CONTINUE AND IV LINE WAS ABLE TO BE USED. NO OTHER ISSUES.(ANNEX A). THE FACILITY ALSO REPORTED THE UNAVAILABILITY OF THE DEVICE INVOLVED IN THE INCIDENT. FOLLOWING THE ABOVE-MENTIONED REPORT, THREE STERILE DEVICES FROM THE AFOREMENTIONED LOT WERE IMMEDIATELY RETRIEVED FROM THE INTERNAL ARCHIVE AND SUBJECTED TO LEAK TESTING. THE VERIFICATION WAS CARRIED OUT TO DETECT ANY POSSIBLE BLOOD LEAKAGE FROM THE REAR PART OF THE CATHETER, WHERE THE SILICONE RUBBER SEPTUM IS LOCATED, DESIGNED TO STOP BLOOD FLOW AFTER NEEDLE WITHDRAWAL FROM THE CATHETER. IN PARTICULAR, THE FOLLOWING TESTS WERE PERFORMED: LOW-PRESSURE HYDROSTATIC LEAK TEST (H. 110 MM) WITH SIMULATED BLOOD THE TEST WAS CONDUCTED BY CONNECTING THE CATHETER TO A RESERVOIR OF SIMULATED BLOOD (GLYCERIN-BASED AND DYED WATER) WITH A FLUID COLUMN PRESSURE OF 110 MM; HIGH-PRESSURE HYDRAULIC LEAK TEST AT 23 BAR IN ORDER TO RULE OUT THE PRESENCE OF LEAKS FROM THE NEEDLE EXIT POINT OR OTHER PARTS OF THE DEVICE AND TO VERIFY ITS FULL EFFICIENCY, A HYDRAULIC PRESSURE TEST AT 23 BAR WAS CARRIED OUT. TO DEMONSTRATE THAT THERE ARE NO LEAKS FROM THE CATHETER BODY SURFACES, INCLUDING THE SEPTUM, AT BOTH LOW AND HIGH PRESSURE, WE PROVIDE THE FOLLOWING ATTACHMENTS: REPORT OF HYDROSTATIC PRESSURE LEAK TEST AT 110 MM WITH SIMULATED BLOOD FOR LOT 11T45107 (SEE ANNEX B); REPORT OF HYDRAULIC PRESSURE TEST AT 23 BAR FOR 1 MINUTE FOR LOT 11T45107 (SEE ANNEX C). FROM THE TESTS CARRIED OUT ON THREE DEVICES TAKEN FROM THE ARCHIVE OF LOT 11T45107, NO LEAKAGE FROM THE SILICONE RUBBER SEPTUM WAS OBSERVED USING SIMULATED BLOOD AT A PRESSURE OF 110 MM FLUID COLUMN AFTER NEEDLE WITHDRAWAL AND EVEN AFTER FIVE MINUTES FROM THE START OF THE TEST. SIMILARLY, DURING THE HYDRAULIC PRESSURE TEST AT 23 BAR, NO LEAKAGE FROM THE SILICONE RUBBER SEPTUM WAS OBSERVED, DEMONSTRATING THAT THE TESTED CATHETERS DO NOT LEAK EVEN AT HIGH PRESSURE AND THAT THE PRODUCT DOES NOT SHOW MANUFACTURING DEFECTS. FOLLOWING THE ABOVE REPORT, DOCUMENTATION RELATED TO THE BATCH RECORD OF THE LOT INVOLVED WAS PREPARED, SPECIFICALLY CONCERNING THE PIERCEABLE SEPTUM CONSIDERED RESPONSIBLE FOR THE LEAKAGE. THE ANALYZED DOCUMENTATION IS DETAILED BELOW: STERILIZATION ORDER NO. (B)(4) DATED 07/06/24 FOR LOT 11T45107, PERFORMED ON 11/06/24 WITH STERILIZATION LOT 240611A15, RELEASED ON 17/06/25 (ANNEX D). DOCUMENT REVIEW DID NOT REVEAL ANY ISSUES REGARDING STERILIZATION PARAMETERS; IN PARTICULAR, TEMPERATURE (PREHEATING, STERILIZATION, DEGASSING), RELATIVE HUMIDITY, QUANTITY OF GAS MIXTURE INTRODUCED INTO THE CHAMBER, AND CYCLE DURATION ALL COMPLY WITH PREDEFINED AND VALIDATED LIMITS. INCOMING RAW MATERIALS: BASED ON INTERNAL TRACEABILITY, TWO LOTS OF PIERCEABLE SEPTA WERE USED FOR THE PRODUCTION OF THE CATHETER SUBJECT TO THIS REPORT: INTERNAL LOT 30072T01102, CODE: 00040016, CONSISTING OF (B)(4) UNITS RECEIVED ON 20-09-2023, FOUND COMPLIANT WITH INCOMING RAW MATERIAL ACCEPTANCE CHECKS (ANNEX E); INTERNAL LOT 30135T01201, CODE: 00040016, CONSISTING OF (B)(4) UNITS RECEIVED ON 06-12-2023, FOUND COMPLIANT WITH INCOMING RAW MATERIAL ACCEPTANCE CHECKS (ANNEX F). CONCLUSIONS: NO MANUFACTURING DEFECTS WERE IDENTIFIED DURING THE INSPECTION OF RETAINED SAMPLES FROM THE SAME LOT REFERENCED ABOVE; INCOMING INSPECTION OF THE SILICONE SEPTA USED IN THE MANUFACTURE OF THE LOT REPORTED DID NOT REVEAL ANY DEFECTS THAT COULD CAUSE LEAKAGE OF THE PIERCEABLE SILICONE SEPTUM UPON NEEDLE WITHDRAWAL; LOT 11T45107 HAS NEVER BEEN SUBJECT TO COMPLAINTS; SINCE THE DEVICE INVOLVED IN THE INCIDENT IS NOT AVAILABLE FOR EVALUATION, THE EXACT CAUSE OF THE LEAKAGE FOLLOWING NEEDLE WITHDRAWAL FROM THE CATHETER CANNOT BE DETERMINED WITH PRECISION, AS WOULD BE POSSIBLE IF THE DEFECTIVE SAMPLE WERE AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 0

    DESCRIBE THE EVENT OR PROBLEM: WHEN THE PERIPHERAL IV WAS INSERTED IN THE PATIENT'S VEIN, BLOOD LEAKED BACK FROM THE PORT. SITE WAS CLEANED AND BLEEDING DID NOT CONTINUE AND IV LINE WAS ABLE TO BE USED. NO OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071961 DELTAVEN FAST FLASH 20G 32MM I.V. CATHETRS WITH CLOSED SYSTEM FOZ DELTA MED SPA 3836773 11T45107 08032248383678

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other