MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; TRAY,FOL,NON-STER,TRAIN,12FR,SIL

Catalog Number	DYND11NS12S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the tip of the syringe breaks off when students try to fill the balloon.This happened to 3 different students and with 3 different kits.".
Additional Manufacturer Narrative
The customer reported that ¿the tips on the syringe keep breaking¿ and that this happened to ¿3 different students and with 3 different kits.¿ medline quality received a photograph of the reported product, and visual assessment of the provided image revealed that the sterile water syringe had broken off into the balloon inflation port.The reported issue was verified by visual assessment of the provided photograph, thus confirming the reported complaint.The cause was documented as ¿comp./part defective, broke,¿ and a retrospective review of the past 6 months preceding the reported issue revealed no additional complaints of broken syringe tips, with no known trends for this product sku.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: TRAY,FOL,NON-STER,TRAIN,12FR,SIL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shirisha mothe ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50668768
• Report Number: 1417592-2026-33649
• Device Sequence Number: 9272713
• Product Code: OHR
• UDI-Device Identifier: 40888277085818
• UDI-Public: 40888277085818
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/03/2026

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: DYND11NS12S
• 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: 08/16/2023
• Initial Report FDA Received Date: 09/08/2026
• 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