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

Model Number MISC

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complaint device has been destroyed and is not available for evaluation.Therefore, this report is based solely on customer-provided information, which includes images of the complaint units.Images revealed that the box stitch joining the foam, wash label, and webbing containing the d-ring remained intact and did not fail; based on photos provided by the customer, failure of the malfunctioned product was in the foam.The investigation concluded that there was an excessive amount of force applied by the patient, causing the foam to tear.Overall, review of the pictures of the complaint devices did not reveal any visual manufacturing issues.The devices appear clean and the labeling is present and legible.Customer submitted photos of the failure indicate that the device performed as can be expected when the instructions for use (ifu) are not followed or certain steps are omitted during device application.Additionally, contraindications in the ifu provide a warning not to 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.According to the user submitted medwatch report and the patient¿s demeanor, this economy limb holder may not be the correct restraint device for this aggressive patient.The root cause for foam failure was identified as failure to follow the recommended ifu steps for application for use or use with a combative behavior, self-destructive behavior patient type which is contraindicated for this product.Historical complaint data review found two other complaints received for this device and failure in the last 2 years, both from this user facility.Posey has performed in-service with the customer and provided on-site training on 25 november 2019.Additional in-service re-training was completed on july 23, 2020.Due to complaints received that the event was recurring after re-training was performed, an internal investigation was launched resulting in the initiation of a change control to revise the ifu to include a warning that the failure may occur if the critical steps are not followed.Additional in-servicing with the user facility will take place upon completion.No further corrective or preventive actions are required at this time.Manufacturing reference file (b)(4).Device not available for return.

Event Description

Per fda report (b)(4) "patient with traumatic brain injury had bilateral soft wrist restraints applied to prevent pulling at life sustaining tubes/lines.Nurse reported that the patient was agitated and ripped through the "economy limb holder." the ring that holds the strap ripped off of the restraint allowing the patient to pull out an iv.The nurse was near to the patient at the time and was able to reach the patient before the patient could self-extubate.The iv was reinserted with no harm to the patient.The wrist restraint was bagged up and sent to the quality department." no product information or gtin provided.No ts completed at this time.

• Brand Name: POSEY ECONOMY LIMB HOLDERS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 6264433143
• MDR Report Key: 10575604
• MDR Text Key: 209629494
• Report Number: 2020362-2020-00109
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2020

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 Operator: No Information
• Device Model Number: MISC
• Device Catalogue Number: MISC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/23/2020
• 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