MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; BED ASSIST BAR

Catalog Number	BA6800
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "bed assist bars will not lock in place on the bed." it was also reported that "customer informed she was able to get one on but not the other" and "customer mentioned when it goes up she is unable to click it in place.".
Additional Manufacturer Narrative
The customer reported that "the unit will not lock in place on the bed.They can get one on but not the other.When it goes up, they are unable to click it in place"; no injury or fall reported.Medline quality has yet to receive the requested information from the customer; follow up to obtain the necessary information was unsuccessful, finished good/component trending was performed, and no trends were identified for the specified material number and its corresponding defect type.Investigation results: not confirmed.Root cause was documented as sample required to determine cause; a formal investigation will be conducted should the customer provide medline quality with a photo, video, or a physical sample, and the division will monitor complaints through 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: BED ASSIST BAR
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: shravan ingole ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946608
• Report Number: 1417592-2026-54301
• Device Sequence Number: 18753508
• Product Code: QTC
• UDI-Device Identifier: 00884389102865
• UDI-Public: 00884389102865
• 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): 09/29/2026

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: BA6800
• Device Lot Number: 88524090003
• 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: 11/21/2025
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown