MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; RESTRAINT, PROTECTIVE

Model Number MDT829099A

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2022

Event Type  malfunction  

Event Description

Patient was placed in 4 point restraints.The locks attached to the strap that are attached to the bed were hard to lock, but they did all close with some effort by staff.However, one of the ankle restraints was untied in order to undress patient and move them up in the bed, and in the attempt to relock it, it would not lock.Multiple attempts were made by different staff members.Once the restraint was removed from the patient, the only way a nurse was able to get the lock to "click" shut was to forcibly step on it on the ground with her foot.She stated she's been having more and more issues with the 4 point nylon restraints locking easily like they're supposed to.

• Brand Name: MEDLINE
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 15743094
• MDR Text Key: 303161336
• Report Number: 15743094
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/13/2022

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 Operator: Health Professional
• Device Model Number: MDT829099A
• Device Catalogue Number: MDT829099A
• Device Lot Number: 33021080001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12775 DA
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Race: Black Or African American