MAUDE Adverse Event Report: UNKNOWN INTRAVENOUS LINE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 06/17/2023

Event Type  Injury  

Event Description

Pt on the line to report a hospitalization on (b)(6) 2023.Iv site was very swollen and painful and eventually dislodged.Pt reports iv was out for just a short period of time before the hospital staff was able to place it back in.The hospital ran a culture on the site and the results have not come back yet.Pts health is currently stable and no further info.Reported to cvs/caremark by: patient/caregiver.

• Brand Name: INTRAVENOUS LINE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17218759
• MDR Text Key: 318138711
• Report Number: MW5118894
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• 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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/27/2023
• Patient Sequence Number: 1
• Treatment: AMBRISENTAN.
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR
• Patient Sex: Female