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

Lot Number 84322020042

Device Problem Product Quality Problem (1506)

Patient Problem Irritability (2421)

Event Date 08/10/2022

Event Type  malfunction  

Event Description

Patient intubated/sedated, vented, restrained for safety.Rn observed patient out of restraints, flailing hands and legs.Patient increasing agitation, precedex increased, bolus of fentanyl given, patient placed back in restraints.Manufacturer response for medline quick release limb holder brand not provided, per site reporter, recently we have had a ton of incident reports pertaining to the new medline restraints failing.We had a call with medline last week to explain our issues and they are currently investigating and are planning a return trip to the hospital to educate nursing again.After about 5 more reports came in today, we are more concerned.No patient or caregiver harm has ensued yet, but this is a huge safety risk.I am working with and the supply chain to have another call with medline and ask that they either replaced the lot numbers with.

• 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: 15264859
• MDR Text Key: 298306646
• Report Number: 15264859
• 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: 08/11/2022

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 Lot Number: 84322020042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Male
• Patient Race: White