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

Model Number 2799

Device Problem Unraveled Material (1664)

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

Event Type  malfunction  

Manufacturer Narrative

(other) - product was requested to be returned and has not been received.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.The instructions for use (ifu) state, "always inspect before each use: check for broken stitches or parts; torn, cut or frayed material." manufacturer reference file no.(b)(4).Pending device return.

Event Description

Customer reported after the arm restraint was applied to the patient his arm became free.Hospital personnel noticed a portion on the restraint where the seam had unraveled and the patient was able to free himself.The date the incident occurred is unknown and no patient or caregiver injury was reported.

Event Description

Supplemental required for additional information.

Manufacturer Narrative

Evaluation of the returned device found loose or broken threads of the box x stitch where the bed-connecting strap is sewn onto the neoprene ankle cuff.The box x stitch has been identified as the failure caused by broken or loose threads.Inspection shows the top and bottom of the stitch remains complete/intact and the broken or loose threads are contained within the plies of the webbing.Observing the ends of the threads through magnified glasses there is a combination of threads that appear to have been pulled and threads that may have been cut.The root cause of the broken or loose threads could not be determined however, based on the information provided by the customer, the age of the device and investigation results of the returned product, it is likely that wear and tear may have contributed to the failure.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 no: (b)(4).

• Brand Name: LOCKING TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCT LLC; 5635 peck rd; arcadia CA 91006
• MDR Report Key: 7401384
• MDR Text Key: 104861524
• Report Number: 2020362-2018-00021
• 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: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2799
• Device Catalogue Number: 2799
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1