MAUDE Adverse Event Report: PIGTAIL EXTENSION TUBING; INTRAVASCULAR ADMINISTRATION SET

Device Problems Contamination (1120); Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/23/2023

Event Type  Injury  

Event Description

Patient reported leaking from the pigtail extension of the cadd pump to the male ll2s equashield adapter.Patient could not receive full dose of 5-fu home infusion.We've had over 20 leaking pumps at our facility.Countless contaminations and exposures of patients from these leaking device.Equashield and infusystem will not take any accountability for these issues.Therapy dates: (b)(6) 2023.Reference report #mw5115053, mw5115054.

• Brand Name: PIGTAIL EXTENSION TUBING
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 16409044
• MDR Text Key: 310040709
• Report Number: MW5115055
• 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: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLUOROURACIL
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic