MAUDE Adverse Event Report: POSEY PRODUCTS LLC QUICK-RELEASE GAIT BELT, STANDARD NAVY (BARIATRIC); AID, TRANSFER

Model Number 6528QL

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Product is scheduled to be returned but has not been received in by manufacturer at the time of this report.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 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 (b)(4).No product returned at this time.

Event Description

Customer reported when he went to release the gait belt from the patient, he noticed one of the prongs was missing from the male portion of the belt.The date the issue was discovered is unknown.No patient injury was reported.

Manufacturer Narrative

Product was received and analyzed.Analysis confirmed the reported issue of the buckle breaking.One of the prongs on the male component side had broken of.Further investigation revealed that the break occurred at the low cross-sectional area with no support structures.The design of the prong is to flex/bend when engaged with the female component of the lock.Inspection of the break area displayed signs of fatigue indicating a crack originated and over time escalated to the reported break.The product had been manufactured over 3 years ago, and it's possible that during the 3+ years, the product may have been under constant tension and began to degrade with time.A review of the complaint history, for this part number, for the past 3 years shows similar damages were reported and the root cause was attributed to wear and tear or excessive force.At this time, it is unlikely the damage was due to a manufacturing non-conformity as the device has been in use for over 36 months.Therefore, no corrective or preventative 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 the failure mode will be assessed, documented and acted upon as warranted.(b)(4).

Event Description

Supplemental required for additional information.

• Brand Name: QUICK-RELEASE GAIT BELT, STANDARD NAVY (BARIATRIC)
• Type of Device: AID, TRANSFER
• Manufacturer (Section D): POSEY PRODUCTS LLC; 5635 peck road; arcadia 91006
• MDR Report Key: 7308578
• MDR Text Key: 101512344
• Report Number: 2020362-2018-00013
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

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: Lay User/Patient
• Device Model Number: 6528QL
• Device Catalogue Number: 6528QL
• Device Lot Number: 4316T024
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 03/01/2018
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 04/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1