MAUDE Adverse Event Report: UKNOWN INF SET QUICK-SET 23" 9MM; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)

Patient Problem Diarrhea (1811)

Event Type  Injury  

Event Description

Spontaneous call from patient's wife.Patients wife reported that she changed his infusion site at around 1:40pm today because the pump alarmed with blockage detected.When she removed the catheter, it was bent so she helped the patient change his site.The patient has been using the same pump since without any further issues.She also reported that the patient has been experiencing increased frequency of diarrhea during this past month.She stated that he did not take any medication to alleviate the diarrhea and it has improved.Unknown if his doctor is aware.Patient is on subcutaneous remodulin therapy.No other information provided.Reported to cvs/caremark by: patient/caregiver.

• Brand Name: INF SET QUICK-SET 23" 9MM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UKNOWN
• MDR Report Key: 15680818
• MDR Text Key: 302604716
• Report Number: MW5112911
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: PUMP; REMODULIN
• Patient Sex: Male