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

Model Number 2791Q

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Customer declined to return device.Historical review of the complaint database found 4 other event with similar issue where the patients were able to release from the restraint.Of the 4 complaints, product was returned for two of the complaints.In both instances, the product was not being used per the instructions for use (ifu).Analysis of one device found it to have a box stitch that was sewn with a high amount of tension that had failed over time, possibly due to incorrect sewing machine settings.There was no patient injury involved in any of the complaints.Sample evaluation found no evidence of manufacturing concern and historical review does not show a trend of product malfunction.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.It is recommended that the restraint not be used on patient who is or becomes highly aggressive, combative, agitated or suicidal.The ifu also provided extra warning to always monitor patient per facility policy.Be aware that constant monitoring may be required for: aggressive or agitated patients; and patients deemed at risk of aspirating their vomit.This includes patients in the supine position, or who are not able to sit up.If the patient vomits, he or she could aspirate the vomit and suffocate.Be prepared to intervene at the first sign of danger.Such patients require frequent review and evaluation of their physical and psychological status.Without return of the device the reported issue could not be confirmed and without the device lot information the release documentation could not be reviewed.At this time there is no evidence that a manufacturing non-conformity 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.Therefore, no 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).

Event Description

Customer reported while the patient is in use with the restraint the patient is able to release themselves from the restraint.The date the issue was discovered is unknown and no patient incident or injury was reported.

• Brand Name: QUICK-RELEASE TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: william hincy ; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 8660683
• MDR Text Key: 146783142
• Report Number: 2020362-2019-00133
• 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: 05/01/2019

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: 2791Q
• Device Catalogue Number: 2791Q
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/01/2019
• Initial Date FDA Received: 05/31/2019
• 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