MAUDE Adverse Event Report: POSEY COMPANY SLEEVED JACKET; RESTRAINT, PROTECTIVE

Model Number 3350

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth, weight: ni.Conclusions: evaluation of the returned product confirmed the tear down the middle from the collar stopping at the top of the sewn strap.Further inspection of the yellow binding for the collar displayed stitching holes on both sides of the binding material suggesting that the collar was properly sewn to the flannel fabric.There were no rips or tears found along the edges of the flannel fabric where the yellow binding is sewn and no threads were found on either the yellow binding or flannel material to inspect.There were no injuries reported as the product was taken out of use at the time of occurrence.In addition, the age of the product and determination if proper laundering was followed could not be determined due to the wash label being removed.A review of the complaint database was performed and did not reveal any similar events.At this time there is no evidence that a manufacturing non-conformity contributed to the reported event, 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.The instructions for use (ifu) were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.The ifu states "before use, check device for damage.Discard device if you have any questions about patient safety." (b)(4).

Event Description

Customer reported the vest ripped through the middle while a nurse was putting it on a patient.There were no patient injuries reported.

• Brand Name: SLEEVED JACKET
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY COMPANY; 5635 peck road; arcadia CA 91006
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6568073
• MDR Text Key: 75327151
• Report Number: 2020362-2017-00016
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/19/2017

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: 3350
• Device Catalogue Number: 3350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1