MAUDE Adverse Event Report: POSEY PRODUCTS LLC UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF; RESTRAINT, PROTECTIVE

Model Number 2700Q

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not available for return.Therefore, this event is based solely on user provided information.Historical complaint data review found 2 other complaints received for patients being able to self-release from this device or similar device, 2700ql.In both cases, the complaint devices were returned and evaluated, and both were found to meet specification.The engineer who designed the 3-point buckle assessed that the middle tab appeared to be not completely engaged or secured, causing the buckle to become a 2-point buckle.The likely cause of the failure is therefore user error.The purpose of the middle tab is to add a degree of difficulty for the patient who is attempting to escape the restraint.If the middle tab is not engaged, a person who is flexible enough to reach the two tabs on the side of the buckle can indeed open the buckle.None of the 3-point buckles on the returned restraints were damaged and worked as intended.A review of the ifu only describes closing the buckle by sliding the male and female components together.It is possible to assume that the buckle is closed when it is actually not.The only distinct way to ensure the buckle is completely engaged, is the sound made when the male and female components are engaged.Without the return of the device the complaint cannot be confirmed.At this time, there is no evidence that a manufacturing nonconformity 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.As a precaution, an internal investigation was initiated to investigate this issue further, assess risk, and determine next steps.Manufacturer reference file #s (b)(4).

Event Description

(b)(6) reported via email an issue regarding item 2700q.One of the patients at the facility was able to unlock/unclip from the device.Customer says they are unable to return the product back.No gtin or lot numbers provided.Troubleshooting guide saved.

• Brand Name: UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 570 enterprise drive; 570 enterprise dr; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 6264433143
• MDR Report Key: 10495021
• MDR Text Key: 206126216
• Report Number: 2020362-2020-00103
• 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: 08/07/2020

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: 2700Q
• Device Catalogue Number: 2700Q
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/04/2020
• 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