MAUDE Adverse Event Report: NIPRO CORPORATION (ODT) NIPRO SAFELET IV CATHETER

Model Number CI+2225-2C

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/19/2023

Event Type  Injury  

Event Description

22 gauge iv catheter cannula which was inserted into saphenous vein on r foot broke during removal.Breakage of 3mm distal tip of cannula on an unsuccessful iv attempt, found tip of plastic catheter broken off and missing upon removal of iv.Highly unusual for it to break like this after using thousands of the same catheters.3 mm catheter tip seen on foot x-ray pt needing further imaging, workup, exploration and surgical removal.

• Brand Name: NIPRO SAFELET IV CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): NIPRO CORPORATION (ODT); 8-7, hanuki-yachi, niida-aza; ohdate-shi, akita 018-5 794; JA 018-5794
• MDR Report Key: 17394148
• MDR Text Key: 319759855
• Report Number: 1056186-2023-00006
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/25/2023

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
• Device Operator: Health Professional
• Device Model Number: CI+2225-2C
• Device Lot Number: 22D04C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/11/2023
• Device Age: 15 MO
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention