MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-MTO,LEFT HEART,KIT

Catalog Number	000000000065030131
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that several of their manifold kits (which arrive in all different packs) were arriving with the check valve on the waste bag made backwards and the tubing was coming packaged so tighly wound together that it was causing kinks and making it very difficult to unwind, especially in emergency situations.The tubing is knotted together and the quality is noticably worse.
Additional Manufacturer Narrative
The account reported check valve backwards and tubing too tight, and that the tubing is knotted together.No stock check was able to be performed as there was no remaining inventory; a photo was received for review, and review of the finished good bill of materials/pack build, finished good manufacturing instructions, and device history record did not reveal any nonconformances related to the reported defect.Based on review of the photo, the reported defect was confirmed as the tubing was wound too tightly; the check valve was placed correctly.Root cause can be attributed to human error, and no further action is required at this time as medline will continue to monitor for additional occurrences and adverse trends.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: DBD-MTO,LEFT HEART,KIT
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: jarred meyers ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946188
• Report Number: 1417592-2026-54197
• Device Sequence Number: 9499212
• Product Code: OEZ
• UDI-Device Identifier: 10193489060065
• UDI-Public: 10193489060065
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: 000000000065030131
• Device Lot Number: 0000098827
• Was Device Available for Evaluation?: No
• 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: 08/21/2024
• Initial Report FDA Received Date: 09/30/2026
• 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