MAUDE Adverse Event Report: MEDSOURCE LABS CURAPLEX; CURASLIDE BC IV CATHETER 18G X 1 1/4"

Model Number	1613-86218
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	03/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
At approximately 1140 on (b)(6) 26, a curaplex® curaslide¿ bc safety iv catheter with blood control, 18ga x 1.25in, was initiated on the patient.The package was opened by the provider and when the provider went to remove the cap of the needle, it came off as usual, but it sounded different.Rather than the typical click sound it usually makes, it felt like there was a double click, or potentially a crack of some kind.The provider thoroughly examined the needle prior to venipuncture and there was no obvious issue noted to the structural integrity of the needle, housing, or catheter.The provider performed the venipuncture with appropriate flash in the chamber and advanced the catheter per standard procedure.The provider held tamponade (though these catheters self-tamponade) and attempted to attach the saline-primed extension set.The provider was unable to get the extension set to attach to the catheter, as it would not enter the catheter hub space.Upon further examination, the provider noticed that the catheter hub was entirely occluded with plastic.(report number: mw5186061).
Additional Manufacturer Narrative
At approximately 1140 on (b)(6) 2026, a curaplex® curaslide¿ bc safety iv catheter with blood control, 18ga x 1.25in, was initiated on the patient.The package was opened by the provider and when the provider went to remove the cap of the needle, it came off as usual, but it sounded different.Rather than the typical click sound it usually makes, it felt like there was a double click, or potentially a crack of some kind.The provider thoroughly examined the needle prior to venipuncture and there was no obvious issue noted to the structural integrity of the needle, housing, or catheter.The provider performed the venipuncture with appropriate flash in the chamber, and advanced the catheter per standard procedure.The provider held tamponade (though these catheters self-tamponade) and attempted to attach the saline-primed extension set.The provider was unable to get the extension set to attach to the catheter, as it would not enter the catheter hub space.Upon further examination, the provider noticed that the catheter hub was entirely occluded with plastic.Investigation of retain samples from the same lot number is pending.

• Brand Name: CURAPLEX
• Common Device Name: CURASLIDE BC IV CATHETER 18G X 1 1/4"
• Manufacturer (Section D): MEDSOURCE LABS; 8600 shelby ct; suite 100; chanhassen MN 55317
• MDR Report Key: 25117132
• Report Number: 3003674698-2026-01253
• Device Sequence Number: 10289406
• Product Code: FOZ
• UDI-Device Identifier: 00810094574161
• UDI-Public: 00810094574161
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: 1613-86218
• Device Catalogue Number: 1613-86218
• Device Lot Number: 50713/0483
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• 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