MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SUPPORT TRAY -K & MC

Catalog Number	DYNJRA1994
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the syringes in his support trays are breaking when he is in use.The plunger is snapping into pieces.He said this is happening frequently.".
Additional Manufacturer Narrative
The account reported that the syringes in the support trays are breaking when in use and the plunger is snapping into pieces; according to the customer, when medication was being injected into "an area of resistance on the patient" the tabs on the syringe broke, the procedure was able to be finished, and it did not affect the medication.No sample or photo was received for investigation; finished good production records were reviewed with no line down situations, run without approvals, substitutions, deviations or non-conformance reports, and the finished good pack build history was reviewed with no issues that would contribute to the reported issue.Due to the actual sample not available, medline was not able to confirm what may have caused the syringe to break.The quality team 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: SUPPORT TRAY -K & MC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: koushik pothamshetty ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50804646
• Report Number: 1417592-2026-43717
• Device Sequence Number: 21485334
• Product Code: PXN
• UDI-Device Identifier: 40195327188857
• UDI-Public: 40195327188857
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 09/16/2026

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: DYNJRA1994
• Device Lot Number: 23FBQ007
• 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: 11/30/2023
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown