MAUDE Adverse Event Report: TIDI PRODUCTS LLC LIMB HOLDER; RESTRAINT, PROTECTIVE

Model Number	2550
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Unintended Extubation (4564)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product was received and evaluated.Visual findings observed two cuffs were returned with 2 different lot numbers: 3262t158 and 3201t004.Velcro is somewhat worn but not damaged.Corners fold inward and the webbing is in good condition, no tears or cuts.Evaluation of the returned product found that one of the cuffs had a backwards buckle.A review of the device history record for lot: 32652t158 found that 1 pair of cuffs was out of material specification but no issue with the buckles.All other products passed verification testing and met manufacturing specification prior to being released for distribution.Customer communication noted that patient was disoriented at the time of the incident.Patient was napping, then had a dream that frightened him, he woke up and pulled at the restraints, resulting in them loosening and patient being able to remove his breathing tube.Possible cause for this event is the incorrect installation of the buckle caused the strap end to face inward instead of outward, making it difficult to properly adjust and secure the cuff.As a result, the cuff may not have been tightened correctly, allowing the patient to escape.The ifu application instructions state always inspect before each use: check for broken stitches or parts; torn, cut or frayed material; or locks, buckles, or hook-and-loop fasteners that do not hold securely.Do not use soiled or damaged products.Doing so may result in serious injury or death.Dispose of damaged products per facility policy for biohazardous material.Always monitor patient per facility policy.Improper application or use of any restraint may result in serious injury or death.Be aware that constant monitoring may be required for: aggressive or agitated patients.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file: (b)(4).
Event or Problem Description
Customer reported: i am the clinical nurse leader in the (b)(6) icu.I wanted to get your insight into a concern that i have with our current wrist restraints.We recently had a patient that was able to self-extubate due to loosening of his bilateral wrist restraints.He was able to demonstrate how he was able to get out of them and after more investigation i found that it really was not difficult to get out of multiple pairs of wrist restraints.I am wondering if having them laundered frequently is loosening the buckle and impacting the velcro.Is this something that other organizations have been reporting? is there a recommendation for how many times the restraints should be washed before they need to be replaced? do you have any thoughts or recommendations regarding how to move forward? i would think that they would be able to be washed at least a few times before the material begins to breakdown.I agree that the restraints should have a visual inspection before use, but the loosening on the strap is not something that you would catch on visual.

• Brand Name: LIMB HOLDER
• Common Device Name: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 21950335
• Report Number: 2182318-2025-00049
• Device Sequence Number: 8535019
• Product Code: FMQ
• UDI-Device Identifier: 10190676004932
• UDI-Public: 10190676004932
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: 2550
• Device Catalogue Number: 2550
• Device Lot Number: 3262T158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown