MAUDE Adverse Event Report: JT POSEY COMPANY LOCKING TWICE-AS-TOUGH CUFFS; RESTRAINT, PROTECTIVE

Model Number 2799

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Note: this report is based solely on the customer reported issue.Note: the instructions for use state: "before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch; cracked or broken buckles or locks; and/or that hook-and-loop adheres securely, as these may allow patient to remove cuff.Discard if device is damaged." (b)(4).Pending product receipt.

Event Description

Customer reported after placing the straps through the hook and loop, the hook and loop closure does not securely lock.The customer did not provide a date when the issue was discovered and no patient incident or injury was reported.

Manufacturer Narrative

Evaluation of the returned cuffs found the metal buckles will lock properly when there are no straps inserted.However, the buckles will require extra force to lock when the straps are inserted due to variability of the buckle opening.The opening on the buckles returned were found to be out of specification.As a result a measuring tool was implemented to test the buckles, which assures more consistent buckle openings.(b)(4).

Event Description

Supplemental required for product evaluation results.

• Brand Name: LOCKING TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): JT POSEY COMPANY; 5635 peck road; arcadia CA 91006
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave. ferrocarril no. 16901. bo; colonia rio tijuana, 3ra. etap; tijuana, mexico 22664 ; MX 22664
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6348042
• MDR Text Key: 68218106
• Report Number: 2020362-2017-00005
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

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: Other Health Care Professional
• Device Model Number: 2799
• Device Catalogue Number: 2799
• Device Lot Number: 5229T043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2017
• Initial Date FDA Received: 02/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2015
• 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