MAUDE Adverse Event Report: Medsource Labs Curaplex; Curaplex CuraSlide BC IV Cath 18G x 1 1/4"

Model Number	1613-86218
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562); Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction

• Brand Name: Curaplex
• Common Device Name: Curaplex CuraSlide BC IV Cath 18G x 1 1/4"
• Manufacturer (Section D): Medsource Labs; 8600 shelby ct; chanhassen MN 55317
• MDR Report Key: 50902747
• Report Number: 3003674698-2026-01345
• Device Sequence Number: 10706425
• Product Code: FOZ
• UDI-Device Identifier: 00810094574161
• UDI-Public: 00810094574161
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K223788
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• 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): 09/25/2026

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: 50652/0441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown