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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Dyspnea (1816)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

No product was returned but leak testing was reviewed in the manufacturing.No issues was found during review of current manufacturing processes.No root cause could determine since the complaint could not be confirmed since no samples or pictures were received for evaluation.No corrective actions are required since the complaint could not be confirmed since no samples or pictures were received for evaluation.

Event Description

Information was received indicating that a smiths medical product was found to be leaking from the little hole in the filter on the tubing.The leak was noticed when the patient found a wet spot on their poop and was unable to breath well.The tubing was changed at this time and the issue was resolved.The patient said that the this was not the first time this happened.This issue occurs approximately every other tubing according to the patient.The patient was using remodulin mdv, 10mg/ml, dose of 154 ng/kg/min, continuous intravenous.There were no reported adverse events.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 11004063
• MDR Text Key: 221453546
• Report Number: 3012307300-2020-12347
• 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: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 11/17/2020
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR