MAUDE Adverse Event Report: TIDI PRODUCTS LLC POSEY DELUXE LIMB HOLDERS; RESTRAINT, PROTECTIVE

Model Number 2631

Device Problem Break (1069)

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

Event Date 02/08/2023

Event Type  malfunction  

Manufacturer Narrative

The assigned tidi territory manager contacted the customer via email asking for more information related to the incident and the return of the product for evaluation, so tidi can investigate and analyze closely the origin of the reported failure.However, the territory manager received a response stating that the issue was identified during setup as the product was new out of the package, or the product never got onto the patient as the item was fraying straight from the package which is inconsistent to the medwatch report received from the fda.The customer reported to the fda that the patient was extremely restless and was able to pull free from the device.The patient was not harmed and was unable to harm himself.The point of failure was on the strap itself as the patient was able to rip the strap simply from his efforts to break free from the wrist restraint.When the territory manager spoke with the site risk manager, she was unclear if they had the product.When the customer was asked via email about the information being inconsistent with the fda report, they became unresponsive with the email.Therefore, this report is solely based on the customer's information.A review of the complaint database did not reveal any similar events against this device in the past 2 years.Therefore, this complaint was an isolated event.A device history record (dhr) of the affected lot number did not reveal any issues that could have contributed to the reported incident.No ncrs were identified.The product passed all verification testing and met manufacturing specifications prior to being released for distribution.The possible root cause of this deficiency is that the pull force applied on the strap material exceeded the threshold rating of the minimum tensile strength which is 200 lbs.Instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.Per the ifu: 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 the 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.Additional or different body or limb restraints may be needed if the patient pulls violently against the bed straps.Without the return of the device, the reported issue could not be confirmed.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.All complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented, and acted upon as warranted.No corrective or preventative actions are necessary at this time.Manufacturer reference file (b)(4).Fda report number (b)(4).H3 other text : product not returned.

Event Description

A posey limb holder made of cotton/flannel-lined was in use on a bed to protect the patient from self-harm.The patient was extremely restless and was able to pull free from the device.The patient was not harmed and was unable to harm himself.Upon closer inspection of the wrist restraint, it was apparent that the fibers were frayed and appeared to become unwrapped.It detached between the base of the triangle shaped wrist wrap and the actual strap, less than one inch from the point of attachment.The tear occurred on the strap itself.It did not come unsewn, nor did it pull free from the wrap.The point of failure was on the strap itself.The patient was able to rip it simply from his efforts to break free from the wrist restraint.

• Brand Name: POSEY DELUXE LIMB HOLDERS
• Type of Device: 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: 17978286
• MDR Text Key: 326185633
• Report Number: 2182318-2023-00099
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676005366
• UDI-Public: 10190676005366
• 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: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/22/2023

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: 2631
• Device Catalogue Number: 2631
• Device Lot Number: 2333T180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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
• Patient Sex: Male