MAUDE Adverse Event Report: PERIPHERALLY INSERTED CENTRAL CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Device Problem Separation Problem (4043)

Patient Problems Hypoxia (1918); Low Oxygen Saturation (2477)

Event Type  Injury  

Event Description

Spontaneous call, (b)(6) calling from the er at (b)(6) hospital.Patient was admitted on unknown date because her peripherally inserted central catheter line fell out and she was hypoxic (79% o2 saturation).The hospital called to ask for patient's most recent intravenous treprostinil dosing on (b)(6) 2022.Details on most recent dose were provided.No further information provided.Length of stay is unknown.Reported to (b)(6) by health professional.

• Brand Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• MDR Report Key: 14437588
• MDR Text Key: 292210612
• Report Number: MW5109796
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: AMBRISENTAN 10MG, MFR: CIPLA USA; TREPROSTINIL
• Patient Outcome(s): Hospitalization
• Patient Sex: Female