MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. QUICK RELEASE LIMB HOLDER; RESTRAINT, PROTECTIVE

Catalog Number MDT821301QL

Device Problem Break (1069)

Patient Problem Fall (1848)

Event Date 08/18/2022

Event Type  malfunction  

Event Description

Patient in black medline restraints, broke restraint.Restraint broke at wrist point and became completely unattached.This resulted in the patient almost pulled out picc line and fell out oob.Manufacturer response for quick release limb holder, (brand not provided) (per site reporter).Unknown.

• Brand Name: QUICK RELEASE LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15274574
• MDR Text Key: 298406848
• Report Number: 15274574
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/18/2022

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 Catalogue Number: MDT821301QL
• Device Lot Number: 84321120037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14600 DA
• Patient Sex: Male
• Patient Weight: 74 KG