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

Catalog Number	650705712
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it felt stripped.Intermittant issue, however i don't recall it ever happening with the old manifold.".
Additional Manufacturer Narrative
The reported issue was that the manifold was connected 2-3 times with heparin saline, and it felt stripped; the issue was intermittent and the customer stated, "i don't recall it ever happening with the old manifold." the dhr could not be performed because no lot number was provided, a 6-month review of complaint history was completed, and product analysis was n/a because no product was returned for evaluation.The customer's reported complaint description cannot be confirmed, no sample was returned for evaluation; without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.No correction is required since no sample was returned for evaluation and a root cause for this event is inconclusive, and no corrective action 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: DBD-MTO,LEFT HEART,KIT,PROVIDENCE,REGEVE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946189
• Report Number: 1417592-2026-54198
• Device Sequence Number: 15827394
• Product Code: OEZ
• UDI-Device Identifier: 10193489075403
• UDI-Public: 10193489075403
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Operator of Device: Health Professional
• Device Catalogue Number: 650705712
• 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: 01/12/2024
• 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