MAUDE Adverse Event Report: UNOMEDICAL A/S INF SET QUICK SET 23" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-392

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Diarrhea (1811); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

Patient's wife reports occasional diarrhea, resolved with imodium.She also reported some minimal blood around the infusion site.She said it is on the skin under the adhesive part that holds the site in place.Advised that the needle could be moving around and tearing up the blood vessels in thee skin which could be the cause of the bleeding.She confirmed no blood in tubing and no signs/symptoms of infection around the site.Recommended she change the site to see if it happens again, and also to clean the old site to prevent infection.Patient is also sending a picture to their cnss.Md is not aware.Rph emailed cnss and md office to make aware.Reported to (b)(6) by pt/caregiver.

• Brand Name: INF SET QUICK SET 23" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNOMEDICAL A/S
• MDR Report Key: 15789200
• MDR Text Key: 303638754
• Report Number: MW5113218
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MMT-392
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male