MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS DIALYSIS FLUID COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Lot Number 22HRO1077

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 12/17/2022

Event Type  malfunction  

Event Description

Combi set/hemodialysis blood tubing set with cat # 03-2622-3 and lot# 22hr01077 was found with unknown foreign material inside the tubing.Tubing was brand new out of the packaging.Was not used on a patient.See scanned pages.

• Brand Name: FRESENIUS DIALYSIS FLUID COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA
• MDR Report Key: 16043423
• MDR Text Key: 306277501
• Report Number: MW5113975
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 22HRO1077
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1