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

Model Number 2551

Device Problems Protective Measures Problem (3015); Patient Device Interaction Problem (4001)

Patient Problem Unintended Extubation (4564)

Event Type  malfunction  

Event Description

Customer states: patient self-extubated within two minutes of me checking both restraints and within 5 secs of me leaving the room (because i expected the restraint to function as it should).After the self-extubation, i noted that the velcro on the left wrist restraint failed, allowing the pt to reach his ett.I replaced both restraints once i discovered the issue.I am very confident that was a device failure because the velcro failed in the exact same way on an entirely new restraint at 0405.I witnessed the velcro failure three times in the span of 15 seconds.Killian was in the room with me when this happened.He witnessed the velcro fail the second two times.

Manufacturer Narrative

Device evaluated by mfr: this report is based solely on the information provided by the customer.Historical review of the complaint database revealed 2 other complaints of unintended patient release.The complaint rate for this part number is very low at (b)(4).No design changes have been made to this product during the past three years.Instructions for use were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch, broken buckles or locks, and/or that hook-and-loop adheres securely as these may allow patient to remove cuff.Discard if device is damaged or if unable to lock.Additionally, the ifu warns do not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.Without the return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be reviewed.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.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).Product was not returned.

Event Description

Supplemental medwatch being sent for additional information.

Manufacturer Narrative

Through communications with the customer it was noted that the patient / staff did not sustain any injuries.The territory manager for this facility found the cause to be due to application issues from newly hired caregivers not trained to the product.Training on correct application was performed by the territory manager (b)(6) which resolved the issue.Instructions for use were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch, broken buckles or locks, and/or that hook-and-loop adheres securely as these may allow patient to remove cuff.Discard if device is damaged or if unable to lock.Additionally, the ifu warns do not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.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).

• Brand Name: LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 16113005
• MDR Text Key: 308836634
• Report Number: 2182318-2022-00148
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676004956
• UDI-Public: 10190676004956
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

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: 2551
• Device Catalogue Number: 2551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1