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

Catalog Number	000000000065191431
Medical Device Problem Codes	Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the rotacting adapter portion of the manifold was cracking or completely disconnceting from the manifold, and this happened at least three times within the last two weeks.A review of the device history records was performed for the indicated packaging and component lots, and the review confirms that the lots met all material, assembly and performance specifications; there have been no previously reported complaints for similar issues and no adverse trends were confirmed.The customer's reported complaint description cannot be confirmed, no sample was returned for evaluation.Without receiving product for evaluation, medline was unable to definitively determine a root cause, and based on no issues noted in the dhr and adequate process controls in place, no corrective action was 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.
Event or Problem Description
It was reported that "the rotacting adapter portion of the manifold is cracking or completely disconnceting from the manifold.This has happened at least three times within the last two weeks.".

• Brand Name: MEDLINE
• Common Device Name: DBD-MTO,LEFT HEART,KIT,SOUTHEAST. ALABAM
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: azmat shah ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50914476
• Report Number: 1417592-2026-51886
• Device Sequence Number: 5330415
• Product Code: OEZ
• UDI-Device Identifier: 10193489063165
• UDI-Public: 10193489063165
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/25/2026

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: 000000000065191431
• Device Lot Number: 0000078583
• 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: 07/14/2023
• Initial Report FDA Received Date: 09/28/2026
• 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