MAUDE Adverse Event Report: Medline ReNewal MEDLINE CO-LABEL; BW CATH CABL THERMCOOL 34PN BLK34PN

Catalog Number	CR3434CTR
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "please process the attached quality complaints.".
Additional Manufacturer Narrative
The complaint received did not include a reason for the complaint, and medical intervention and adverse patient consequence were reported as no.The device was returned to the sub-contractor for investigation, which included review of the original manufacturing records and evaluation of the device, including visual inspection.Upon visual inspection, a bent pin was found in the cable's connector; thus, this complaint is able to be confirmed.The cause code was documented as osi: shipping damage, medline facility, and the record states complaints are trended and monitored to ensure no systemic issues exist.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE CO-LABEL
• Common Device Name: BW CATH CABL THERMCOOL 34PN BLK34PN
• 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: 50937999
• Report Number: 3032391-2026-00225
• Device Sequence Number: 16136077
• Product Code: IKD
• UDI-Device Identifier: 20197344014160
• UDI-Public: 20197344014160
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• 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: CR3434CTR
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/08/2023
• 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: 11/03/2023
• 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