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

Model Number 2532

Device Problem Break (1069)

Patient Problem Extubate (2402)

Event Type  malfunction  

Manufacturer Narrative

The device was not able to be returned or evaluated because it was destroyed by the customer.This report is based primarily on the information provided by the customer.Contraindications in the ifu state 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 self.It is currently unknown as to whether the patient exhibited any of these conditions.Based on specific ifu warnings which state improper application or use of any restraint may result in serious injury or death, never alter or repair this product and always inspect the product before each use.Instructions for use were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.This incompatibility described is often overcome by adjusting how the product is applied to the bed.There are two loops on our 2532 connecting strap, and looping through the one closest to the buckle will shorten the strap and drop the buckle slightly, therefore the quick-release function is visible.This application process is described in the product instructions for use.Manufacturing documentation could not be reviewed because the customer did not provide a lot number for the device.Historical data found complaints of unintentional patient release for the 2532 foam limb holder.Of those returned, broken clips, excessive force, and/or wear and tear has contributed to the malfunction.Other complaints of straps slipping or loosening could not be confirmed.The customer provided one image of the complaint device that appears to show that the male portion of the quick release buckle is broken.The clips breaking on 2532 is a known issue and is being handled per a supplier corrective action request.At this time, no further 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).Device unavailable for evaluation.

Event Description

Customer contacted us via e-mail.Customer states that using product 2532 an icu patient who was restrained was successful in removing his ng tube.Customer states that there is an incompatibility of their current corporate formulary soft wrist restraints with their regular icu beds where the anchor points and the bed rails interrupt the quick release of the clip.The strap gets stuck between the rail and the bed.The nurses have said it is the position of the clip and the short length of the strap that connects at the anchor point.A ts template has been completed and saved to the drive.No gtin information is available.Information given was limited.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: chris rahn ; 5635 peck road; neenah, WI 54956 ; 6264433143
• MDR Report Key: 10708974
• MDR Text Key: 212508366
• Report Number: 2020362-2020-00117
• Device Sequence Number: 1
• Product Code: FMQ
• 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
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2532
• Device Catalogue Number: 2532
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2020
• 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
• Patient Outcome(s): Other