MAUDE Adverse Event Report: MEDSOURCE LABS LLC. CURAPLEX; CURASLIDE BC IV CATHETER 20G

Model Number	1613-86220
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The needle was still inside the catheter after hitting the needle retract button.The catheter was inside of the patient's arm.

• Brand Name: CURAPLEX
• Common Device Name: CURASLIDE BC IV CATHETER 20G
• Manufacturer (Section D): MEDSOURCE LABS LLC.; 8600 shelby ct suite 100; chanhassen MN 55317
• MDR Report Key: 22669426
• Report Number: 3003674698-2025-01033
• Device Sequence Number: 7486818
• Product Code: FOZ
• UDI-Device Identifier: 00810094574185
• UDI-Public: 00810094574185
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K223788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 1613-86220
• Device Lot Number: 40758/0456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown