MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. MEDIPORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 21-4475-24

Patient Problem Hematoma (1884)

Event Date 07/25/2023

Event Type  malfunction  

Event Description

Patient taken to operating room for mediport insertion.During procedure, 2 mediport kits and a separate introducer kit were wasted because the catheter would not advance through the sheath.Successful placement after use of 3rd mediport kit.Patient developed large hematoma while in recovery as a result of multiple attempts to place.Refence report: #mw5120331.

• Brand Name: MEDIPORT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.
• MDR Report Key: 17423990
• MDR Text Key: 320147771
• Report Number: MW5120330
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/26/2023

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
• Device Operator: Health Professional
• Device Model Number: 21-4475-24
• Device Lot Number: 4378527
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2023
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 143 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White