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

Device Problem Component Missing (2306)

Patient Problem Blurred Vision (2137)

Event Date 02/17/2023

Event Type  Injury  

Event Description

Patient given ertapenem injection 1g per day to be infused.Patient reported no issues in first few days.For 2 days, patient reported blurry vision (which would last 10-15 minutes) approximately 4 hours after infusion.Patient informed that his tubing didn't have a filter the 2 days he got symptoms, and when the filter was used again, the blurry vision stopped.Anecdotal, but lack of filter may increase side effects?.

• Brand Name: TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 16438063
• MDR Text Key: 310318250
• Report Number: MW5115174
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian