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

Model Number 2798

Device Problem Break (1069)

Patient Problem Bruise/Contusion (1754)

Event Type  Injury  

Manufacturer Narrative

Associated with medwatches 2020362-2018-00025 and 2020362-2018-00028.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.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 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 warranted.Manufacturer reference file #(b)(4).

Event Description

Customer reported a patient was able to break the straps by rocking the bed back and forth.He was able to free his left arm the 1st and 2nd time.The 3rd time he was able to free his right arm.Because the patient was able to free himself he punched an officer in the head who suffered bruising.The date the issue occurred is not known.Additional information provided stated the officer received minor medical treatment and has since returned to work with no further issues.

Manufacturer Narrative

Additional information provided by the customer stated the officer was received minor medication treatment and has since returned to work with no further issues.Analysis confirmed customer's complaint of the strap breaking.Tensile testing was performed on the product and on new samples, but a root cause analysis could not be determined.It is possible constant tensile strength applied to the product over time may have an effect on the stitching which may cause the threads to degrade and the stitching to weaken over time.Lot number of product indicated this unit had been manufactured over 2 years ago with signs of previous use.The device was lined with lint, dirt and other particles.The hook and loop portion was also fraying.It is likely that wear and tear contributed to the failure.Historical review of the complaint database showed 5 other events where similar products suffered the same stitching/thread issues.Failure analysis showed possible causes was from wear and tear.No serious injury was associated with any of events.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.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." therefore, not corrective or preventive actions are necessary.All complaint 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

Supplemental required for additional information.

• 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: 7463477
• MDR Text Key: 106583992
• Report Number: 2020362-2018-00027
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Model Number: 2798
• Device Catalogue Number: 2798
• Device Lot Number: 5272T004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Date Manufacturer Received: 04/03/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention