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

Model Number MDT821301QL

Device Problems Device Slipped (1584); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

The buckles on multiple restraints did not click into place-they slide in and out without locking.Some of the buckles have snapped when patient is restless and/or agitated and pulls at limb restraints.One of the restraints actually ripped-the canvas that is sewn to outside of the black restraint ripped away.All of these issues occurred with the same patient.He is not aggressive, but he is 6 foot 2 maybe 6 foot 4, confused, disoriented, and very strong.Many staff have had near misses of being kicked or punched during patient care activities and with attempts to redirect and settle.Risk for injury with patient care persists when limb restraint fails.

• Brand Name: MEDLINE
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15182371
• MDR Text Key: 297445568
• Report Number: 15182371
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2022

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 Model Number: MDT821301QL
• Device Catalogue Number: MDT821301QL
• Device Lot Number: 33022030001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/08/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Male