MAUDE Adverse Event Report: FILTER DISK 0.2 MICRON; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2021

Event Type  malfunction  

Event Description

Spontaneous call from patient and infusion nurse both called in stating the filter disk was defective as it would not let the infusion flow through it.Her nurse made "do" with something else, so she did get her infusion.No other information available.Reported to (b)(6) by health professional.

• Brand Name: FILTER DISK 0.2 MICRON
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12835703
• MDR Text Key: 281074539
• Report Number: MW5105448
• Device Sequence Number: 1
• Product Code: FPA
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2021
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female