MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CANNULA,OXY,ADULT,SUPERSOFT,W/7'TUB,SC

Catalog Number	HCSS4514S
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "right after plug in, plastic crimps rght after connects tube s over and crimps".
Additional Manufacturer Narrative
The customer reported that the product ¿crimps once connected¿ and that the issue occurred ¿right after plug in¿ with the plastic crimping right after the tube connects; customer is using this with an inogen one.Medline quality received a complaint for one unit and visually inspected the sample, observed it was new and still wrapped in the original packaging, then opened the sample and verified it met product specifications.Based on the information provided and drawing of the complaint that arrived with the sample, medline could not confirm a root cause, and the defect was not confirmed with the received sample.However, medline confirmed the oxygen cannula meets product specifications, notified the manufacturing site of the issue on a quarterly basis, and the division will monitor the complaint during quarterly trending.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: CANNULA,OXY,ADULT,SUPERSOFT,W/7'TUB,SC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50801561
• Report Number: 1417592-2026-43241
• Device Sequence Number: 8596955
• Product Code: CAT
• UDI-Device Identifier: 40888277306272
• UDI-Public: 40888277306272
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/15/2026

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: HCSS4514S
• Device Lot Number: 74921110001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/23/2023
• 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: 03/15/2023
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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