MAUDE Adverse Event Report: MEDSOURCE LABS LLC CURAPLEX; CURAPLEX IV CATHETER, CURASLIDE 18G X 1.25"

Model Number	1612-84130
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
When i removed the needle portion from the hub, the hub was no longer attached to the catheter.The catheter was not able to be seen protruding out of the skin to be removed.The catheter was completely inside the vein.

• Brand Name: CURAPLEX
• Common Device Name: CURAPLEX IV CATHETER, CURASLIDE 18G X 1.25"
• Manufacturer (Section D): MEDSOURCE LABS LLC; 8600 shelby ct suite 100; chanhassen MN 55317
• MDR Report Key: 22072461
• Report Number: 3003674698-2025-00939
• Device Sequence Number: 9500865
• Product Code: FOZ
• UDI-Device Identifier: 00817617022369
• UDI-Public: 00817617022369
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K150611
• 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): 05/22/2025

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: 1612-84130
• Device Catalogue Number: 1612-84130
• Device Lot Number: 40194/0115
• 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: 04/15/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Sex: Unknown