MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; RAIL,CLAMP-ON HALF F/ MEDLINE HMC

Catalog Number	MDS89697
Medical Device Problem Codes	Activation Problem (4042); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "per pt she has hospital bed w/rails on both sides.One rail fell off and other is not working.".
Additional Manufacturer Narrative
The customer stated that "she has a hospital bed with rails on both sides.One rail fell off and the other is not working," and customer reports she has had the rails for over a year, couldn't really provide any more details on the issues she is having with the rails.A photo was provided; based on the photos, the product appears to be in used condition, the left side half rail is not visible, and the right side half rail is removed from the bed and placed upside down next to the bed.The investigation results were not confirmed, and it does not appear that anything is broken on the right half rail; a physical sample was not provided, and a functional or dimensional inspection cannot be executed via a photo.Based on the review of the details provided for the complaint investigation, medline is unable to confirm the complaint issue or that the product failed to meet specifications, and no reported death or serious injury was associated with this event.There were no reports of death, serious injury, medical intervention, or follow up care.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: RAIL,CLAMP-ON HALF F/ MEDLINE HMC
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: namirah khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50476520
• Report Number: 1417592-2026-25806
• Device Sequence Number: 21413437
• Product Code: FNJ
• UDI-Device Identifier: 40080196746027
• UDI-Public: 40080196746027
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/27/2026

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: MDS89697
• Device Lot Number: 88521100001
• 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: 01/29/2024
• Initial Report FDA Received Date: 08/27/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown