MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; RAIL, XTRA TALL(SOLD AS PAIR),F/FCE

Catalog Number	FCE1232RSRXT
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the screw that holds the bed from going down when pressing the release button is loose/won't screw in properly.It will not hold the rail in the position that they choose anymore.".
Additional Manufacturer Narrative
It was reported that the screw that holds the bed from going down when pressing the release button is loose and won't screw in properly, and it will not hold the rail in the position that they choose anymore; no injuries were reported.Medline received 1 each of xtra tall rails in used condition and checked this, determining it is not a screw but a locking pin that fell out; the customer used black tape to hold it in place, and the product was inspected per pic-00374.The customer complaint was confirmed, and the result of the pic testing was functional defect.The locking pin fell out due to a missing c-clip, which is needed for the locking mechanism to work as designed; the c-clip was not returned, and the cause was recorded as cannot determine cause w/received sample.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: RAIL, XTRA TALL(SOLD AS PAIR),F/FCE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50872167
• Report Number: 1417592-2026-49256
• Device Sequence Number: 9425552
• Product Code: FNL
• UDI-Device Identifier: 40080196326106
• UDI-Public: 40080196326106
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 09/23/2026

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: FCE1232RSRXT
• Device Lot Number: 54122100001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/11/2025
• 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: 01/06/2025
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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