MAUDE Adverse Event Report: DELTA MED SPA DELTAVEN FAST FLASH; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	3836773
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Leaking from the port where the needle separates from the catheter.I inserted it leaks and then i asked another nurse to insert another one still leaking when we flushed.We decided to leave it on for a while like 15 mins or more and flushed it again, no leaking was noted.After flushing with ns [normal saline] it started to leak from the white plastic port (part that's exposed after taking out the needle).I placed another iv using another 20 g and also leaked.But after some time (few minutes) they both stopped leaking.The leaking was sort of slow "ooze" and not continuous leak, and it happened after flushing.

• Brand Name: DELTAVEN FAST FLASH
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): DELTA MED SPA; 4545 n ocean blvd apt 11a; boca raton FL 33431
• MDR Report Key: 25689824
• Report Number: 25689824
• Device Sequence Number: 9687668
• Product Code: FOZ
• UDI-Device Identifier: 08032248383678
• UDI-Public: (01)08032248383678
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/26/2026
• Report Date (Section F): 05/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3836773
• Device Catalogue Number: 3836773
• Device Lot Number: 11T45107
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 05/27/2026