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

Model Number	1612-84130
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562); Blocked Connection (2888); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user started the iv and when the needle was retracted it appeared to not go in all the way.Upon further review when the user attempted to connect an extension set it was noticed that there was a piece of plastic inside the hub of the catheter.The user discarded the used catheter so it was not able to be returned for evaluation.The user was also unable to provide the lot number of the device so an investigation of retain samples from the same lot is not possible.Based on the description of the event, it is likely that part of the needle cover broke off into the hub.
Event or Problem Description
The user started the iv and when the needle was retracted it appeared to not go in all the way.Upon further review when the user attempted to connect an extension set it was noticed that there was a piece of plastic inside the hub of the catheter.

• Brand Name: CURAPLEX
• Common Device Name: CURAPLEX IV CATHETER, CURASLIDE 18G X 1.25"
• Manufacturer (Section D): MEDSOURCE LABS; 8600 shelby ct; suite 100; chanhassen MN 55317
• MDR Report Key: 25117356
• Report Number: 3003674698-2026-01268
• Device Sequence Number: 16036954
• Product Code: FOZ
• UDI-Device Identifier: 00817617022369
• UDI-Public: 00817617022369
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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
• Operator of Device: Health Professional
• Device Model Number: 1612-84130
• Device Catalogue Number: 1612-84130
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown