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

Catalog Number REF- MDT82301QL

Device Problems Break (1069); Defective Component (2292); Connection Problem (2900); Activation, Positioning or Separation Problem (2906)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

Plastic buckle on medline quick-release limb holder - product reference (b)(4) completely broke and came off canvas tie.Nurse able to grab the patients arm to prevent self-extubation.New set of restraints grabbed and neither one of the pair were able to click into the new bottom anchor.Patient switched to posey limb-holder restraints instead.Manufacturer response for limb holder, quick release limb holder (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: 15257686
• MDR Text Key: 298248122
• Report Number: 15257686
• 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 Catalogue Number: REF- MDT82301QL
• Device Lot Number: 84321120037
• 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: 08/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Sex: Female