MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MTO,NAMIC,CUSTOM,KIT,BAK-0157,-,PG

Catalog Number	65690197
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tubes were kinking.
Additional Manufacturer Narrative
The reported issue was tubing was kinking.A review of the device history records was performed for the reported packaging material and component, and the review confirms the batches met all material, assembly and packaging specifications; the samples were not returned to medline, but the customer did provide photos of the reported issues.Based on the photos provided by the customer, the product exhibits some flat spots and dents in the fluid deliver sets, and the complaint is not confirmed for kinks.The tubing can develop dents or flattened spots as it rests against itself or other components within the pouch; dhr review revealed no quality related issues or manufacturing deficiencies at the time of manufacture, and based on no adverse trends, no issues noted in the dhr, and adequate process controls in place, no additional corrective actions to be taken by medline at this time.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
• Common Device Name: MTO,NAMIC,CUSTOM,KIT,BAK-0157,-,PG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: william abrams ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50931505
• Report Number: 1417592-2026-52896
• Device Sequence Number: 9734365
• Product Code: OEZ
• UDI-Device Identifier: 10193489064278
• UDI-Public: 10193489064278
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/28/2026

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: 65690197
• Device Lot Number: 0000048910
• Was Device Available for Evaluation?: Yes
• 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: 07/06/2023
• Initial Report FDA Received Date: 09/29/2026
• 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