MAUDE Adverse Event Report: NULL; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the patient was admitted yesterday morning for a stomach ileus issue and does not have an expected discharge date yet.It was also mentioned an issue with patient's tubing last week.Details not provided regarding what the issue with the tubing was.The patient was off the medication for 14 minutes due to this.No reported issues since this.No additional information, details, or dates available.The reported product fault occurs while in use with the patient.The product issue did not cause or contribute to patient or clinical injury.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 16502988
• MDR Text Key: 310894237
• Report Number: 3012307300-2023-02161
• Device Sequence Number: 1
• Product Code: FPA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1