MAUDE Adverse Event Report: NULL; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Device Problem Leak/Splash (1354)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/23/2021

Event Type  malfunction  

Event Description

It was reported that a new iv placed in right upper arm.An hour later iv infiltrated.New iv placed in left hand, heplocked, multiple staff members involved with placing ivs fluid mandatory due to hypotension - multiple mds had to be contacted during middle of the night because of inconsistent iv access.No further adverse patient effects were reported.

• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section G): NULL
• MDR Report Key: 11743160
• MDR Text Key: 247900908
• Report Number: 3012307300-2021-03563
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1