MAUDE Adverse Event Report: POSEY COMPANY CLEAN CUFFS, KIT; RESTRAINT, PROTECTIVE

Model Number 2216

Device Problems Break (1069); Detachment Of Device Component (1104)

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: instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.(b)(4).Pending product receipt.

Event Description

Customer reported that the clamp/locking mechanism had the pin break right out of the ankle restraint.This reportedly occurred after its second use.The date the issue was discovered is unknown and no patient incident or injuries were reported.

Manufacturer Narrative

Conclusions: after unsuccessful attempts to retrieve additional information regarding the patient and product return, the reported pin break could not be confirmed.With only the information available, a complaint recreation could not be performed as there was not enough information on how the device was being used on the patient.A sample evaluation was conducted; however, it did not confirm the reported issue as the sample functioned as intended with no issues of components breaking.Furthermore, there were no injuries reported.At this time there is no evidence that a manufacturing non-conformity contributed to the reported issue.The instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Historical data did not reveal any similar issues in the last 36 months.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.(b)(4).

Event Description

Supplement medwatch required for additional information.

• Brand Name: CLEAN CUFFS, KIT
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY COMPANY; 5635 peck rd.; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6553091
• MDR Text Key: 74892625
• Report Number: 2020362-2017-00012
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2216
• Device Catalogue Number: 2216
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2017
• 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: Initial
• Patient Sequence Number: 1