MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; QHS CENTRAL LINE OVAL DRESSING

Catalog Number	DYNDC2310D
Medical Device Problem Codes	Mechanical Problem (1384); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screen area of the dressing is damaged when the backing is pulled from the dressing.The dressing is difficult to use after the backing is pulled off.
Additional Manufacturer Narrative
The customer reported that the screen area of the dressing is damaged when the backing is pulled from the dressing and the dressing is difficult to use after the backing is pulled off; the issue did not occur during use and no injury occurred.No sample or photo was received for the investigation, the packs production record could not be reviewed due to the absence of a lot number, and a review of the packs bill of materials confirmed that the pack contains 1 ea of item 52411, drsg opsite 3.5 x 4.75, with no notable issues or defects with the pack that could have contributed to the reported issue.At this time, medline was unable to confirm the reported defect, as no physical sample and no detailed photographic evidence was provided to support the investigation; no root cause was identified.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: QHS CENTRAL LINE OVAL DRESSING
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sangameswaran saravanakumar ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50914614
• Report Number: 1417592-2026-51905
• Device Sequence Number: 14784908
• Product Code: OFF
• UDI-Device Identifier: 10195327449957
• UDI-Public: 10195327449957
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: DYNDC2310D
• 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: 01/05/2026
• Initial Report FDA Received Date: 09/28/2026
• 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