MAUDE Adverse Event Report: POSEY PRODUCTS LLC NON-LOCKING TWICE-AS-TOUGH ANKLE CUFF; RESTRAINT, PROTECTIVE

Model Number 2791

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This device is expected to be returned for evaluation but has not yet been received by manufacturer.A historical complaint review was performed for the past four years.There was one past complaint of a related nature.This complaint was for the strap releasing when the limb strap is placed over the top of the cuff, through the two d-rings and back over the first ring.The device was received, evaluated and found to meet specifications.The customer provided a video demonstrating the reported complaint.This video was reviewed and analyzed internally by engineering personnel.From the video, it appears that the d-rings were located and manufactured in the correct locations, and that the user did initially loop the strap though the two d-rings correctly.The customer video demonstrates an unintended product use.Per the video demonstration, the physical requirements involved to manually manipulate and flip the d-rings require two highly dexterous hands.In the event of at least one restraint were in use on an upper limb, manual manipulation of the device would be challenging for a patient to perform.The unintended use depicted by the customer provided video has been previously identified and is considered an acceptable level of risk per the product risk file review.If the strap does not stay secured, it may allow the unintentional release of the patient.The manual manipulation of flipping the d-rings shown in the video allows the strap to release.This manipulation would be possible if the strap was not pulled tight and under tension.This is a limitation of the design and this specific product is not intended to prevent tampering.If required, posey offers other restraint products that can prevent this type of tampering.Without return of the device, the device is unable to be evaluated.Despite attempts for further information, the device lot information was unable to be provided.Therefore, the device history record and release documentation could not be reviewed for this complaint.At this time there is no evidence that a manufacturing non-conformity contributed to the reported complaint.The instructions for use were reviewed and provide adequate instructions and warnings for the safe and effective use of the device.This event does not appear to be related to a product malfunction or manufacturing defect; no corrective or preventative actions will be performed at this time.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 appropriate actions taken as warranted.Manufacturer reference file #2019-01526.

Event Description

The customer is reporting potential flaws found within the 2790 and 2791 restraints.No further information was received.Video demonstration sent by the customer.The date the issue was discovered is unknown and no injury was reported.

• Brand Name: NON-LOCKING TWICE-AS-TOUGH ANKLE CUFF
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 6264433143
• MDR Report Key: 9387398
• MDR Text Key: 191177839
• Report Number: 2020362-2019-00215
• 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: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2791
• Device Catalogue Number: 2791
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2019
• 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