MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CANNULA,ADULT,SOFT-TOUCH,7TUBE,SC

Model Number	HCS4514
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes 7 malfunction events that occurred between (b)(6) and (b)(6) 2024.The account reported that nasal cannulas (hcs4514) contained pin holes in the tubing, resulting in visible bubbles during use.No patient information was available.No patient or user injuries were reported.
Additional Manufacturer Narrative
This vmsr submission is part of a retrospective data remediation review.The included events represent 7 malfunction events that medline became aware of during april 1, 2024 through june 30, 2024.Associated lot numbers 49123090002, 49123090005, and 74923090004.7 units of hcs4486 were returned for evaluation following reports of pin holes in the tubing.Medline quality received the samples and performed visual and functional evaluation.The samples arrived new in packaging and no visual defects were identified.The tubing was completely submerged in water while 5 liters of air was passed through the tubing.No leaks were identified during testing.The investigation summary documented the reported issue under item hcs4514 involving lot 49123090002 (5 units), lot 49123090005 (1 unit), and lot 74923090004 (1 unit).Based on the evaluation, the reported issue could not be confirmed and the cause of the reported condition could not be determined.7 devices were returned for evaluation.The devices were labeled for single use.No devices were identified as reprocessed or reused.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,ADULT,SOFT-TOUCH,7TUBE,SC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfiield IL 60093 -275
• Manufacturer Contact: nitish sandadi ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50370186
• Report Number: 1417592-2026-20807
• Device Sequence Number: 18635675
• Product Code: CAT
• UDI-Device Identifier: 40080196802884
• UDI-Public: 40080196802884
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 7
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/19/2026

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 Model Number: HCS4514
• 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: Not provided
• Initial Report FDA Received Date: 08/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown