MAUDE Adverse Event Report: Medline ReNewal MEDLINE CO-LABEL; SJM SUPREME CATH FIXED CRD1 4POLE 5MM 6F

Catalog Number	401474RH
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE CO-LABEL
• Common Device Name: SJM SUPREME CATH FIXED CRD1 4POLE 5MM 6F
• Manufacturer (Section D): Medline ReNewal; 1500 ne hemlock avenue; redmond OR 94456 -187
• Manufacturer Contact: brianna montgomery ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50938422
• Report Number: 3032391-2026-00236
• Device Sequence Number: 21519903
• Product Code: NLH
• UDI-Device Identifier: 10197344044351
• UDI-Public: 10197344044351
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K241156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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
• Device Catalogue Number: 401474RH
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown