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

Model Number 2798

Device Problems Material Separation (1562); Unraveled Material (1664)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Product was received in by manufacturer, but at the time of this report, the evaluation has not concluded yet.Therefore, this report is based solely on the information provided by the customer.The instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of this device.The ifu states "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".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 the material is unraveling at the strap and cuff area near the lock.The date the issue was discovered is not known and no patient or caregiver incident or injury was reported.

Event Description

Supplemental required for additional information.

Manufacturer Narrative

Event problem and evaluation updated based on analysis of product.The product was received in with loose threads at the bed-connecting strap and the cuff resulting in separation of the strap.Review of the threads noted unraveling of the yarns or stretching of the fibers.This failure is likely caused by tension applied resulting in the break.Based on the information provided, the source of the force could not be determined.Each material of the device was measured and found to be within product specifications.However, the unit is non-functional in the current state due to the separation of the strap.Review of similar complaints in the past three years found failures related to failed box stitching but no root cause could be determined.No serious injury was noted on any of the other complaints.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warning 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 warrant.Manufacturer reference file #(b)(4).

• Brand Name: LOCKING TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia 91006
• MDR Report Key: 7657151
• MDR Text Key: 113182863
• Report Number: 2020362-2018-00049
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

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: Nurse
• Device Model Number: 2798
• Device Catalogue Number: 2798
• Device Lot Number: 7194T052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 09/14/2018
• Supplement Dates FDA Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1