MAUDE Adverse Event Report: POSEY COMPANY FOAM LIMB HOLDER; RESTRAINT, PROTECTIVE

Model Number 2520

Device Problem Torn Material (3024)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned foam limb holder pair found the foam material is dirty and is coming apart at the wrist strap box stitch.The apparent cause is excessive force however a root cause is being investigated.The instructions for use were reviewed and found to provide adequate instructions and warnings for safe and effective use of the device.(b)(4).

Event Description

Customer reported while the restraint was in use with the patient, the material that the strap is attached to tore.As a result, the patient was able to break free of the restraint and pull out their endotracheal tube.No serious injuries were reported.

Manufacturer Narrative

Conclusion: the reported malfunction was confirmed.The tear on both foam cuffs started where the box stitch is applied, which secures the strap.Further observation revealed the tensile forces applied onto the strap appeared to have transferred to the box stitch on the foam cuff.The tensile force applied was greater than the strength of the foam and not the box stitch.A sample was removed from inventory to duplicate the failure experienced by the returned products.Both restraints were secured to the wrist and the secure straps to the leg on a table.Tensile force was applied to the restraint causing tension on the straps, no tear was experienced.Additional force was applied which caused the foam cuff to tear in the same area as the returned products.The failure was able to be duplicated.There have been extensive attempts to request additional information concerning the patient during the incident.There have been no responses to the inquiries; therefore, it is unknown whether or not there was an injury during this incident.A review of the ifu contains contraindications stating, "do not use on a patient who is or becomes highly aggressive, combative, agitated, or suicidal".At this time, with only the information available, the root cause of the reported issue cannot be determined.All complaints are trended and reviewed by management on a monthly basis.As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.No corrective or preventative actions are necessary at this time.Manufacturer reference file #(b)(4).

Event Description

Supplemental is required for additional investigation results.

• Brand Name: FOAM LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY COMPANY; 5635 peck rd.; arcadia CA 91006
• Manufacturer (Section G): POSEY, S. DE R.L. DE C.V.; ave. ferrocarril no. 16901. bo; colonia rio tijuana, 3ra. etap; tijuana, mexico
• Manufacturer Contact: william hincy ; posey company; 5635 peck road; arcadia, CA 91006 ; 6264433143
• MDR Report Key: 6562361
• MDR Text Key: 75147105
• Report Number: 2020362-2017-00014
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K963413
• 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,Followup
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 2520
• Device Catalogue Number: 2520
• Device Lot Number: 6342T032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2016
• 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