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

Catalog Number MDT821301QL

Device Problems Crack (1135); Defective Component (2292); 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

Two sets of new medline quick-release limb holder restraints out of packaging that do not click into the bottom bed anchor.One of the bottom anchors the plastic is cracked - the other one intact, but still does not click in.Product reference number: (b)(4).Both lot number 33022030001.Manufacturer response for 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: 15257678
• MDR Text Key: 298224965
• Report Number: 15257678
• 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: MDT821301QL
• Device Lot Number: 33022030001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1