MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; MMII,2V,200S,RH,ON,PG

Catalog Number	000000000070038202
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 manifolds broke during their ventrical injection with their medrad injector.
Additional Manufacturer Narrative
The account reported two manifolds broke during their ventrical injection with their medrad injector, and the reported issue was ra separated from manifold.A photo and physical sample were received to aid the investigation; finished good production records and finished good pack build were reviewed, with no instances of line downs, run withouts, deviations, non-conformance reports, or non-conformances noted that would have contributed to the reported issue.The same manifold was observed with the ra separate from the body, confirming the customer's report.The root cause of the rotating adaptor separating from the manifold body was determined to be an inadequate swage during the assembly process of the manifold, and the division will monitor this issue for trending purposes.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: MMII,2V,200S,RH,ON,PG
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: shivani gheewala ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50856759
• Report Number: 1417592-2026-47941
• Device Sequence Number: 13138750
• Product Code: DTL
• UDI-Device Identifier: 10193489064971
• UDI-Public: 10193489064971
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K2095
• 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): 09/22/2026

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: 000000000070038202
• Device Lot Number: 0000157132
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2025
• 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: 09/12/2025
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (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