MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. INF SET CLEO 31" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2021

Event Type  Injury  

Event Description

Spontaneous call from patient who reported that when she woke up around 6:30am this morning, she noticed that her site (including catheter) had completely ripped out.She stated the pump kept pumping the medication after the tubing and catheter was detached from her body.She stated that it is likely that she has been off remodulin for over 4 hours and possibly longer.She denies any trouble breathing or side effects.Her doctor has been informed about the situation.No other information provided.No other info provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: INF SET CLEO 31" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 11738014
• MDR Text Key: 248068397
• Report Number: MW5101047
• Device Sequence Number: 1
• Product Code: FPA
• 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: 04/23/2021

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
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20 YR