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

Model Number 2510

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Evaluation results: visual findings observed only a single restraint being received with labeling present and legible.The product was received in two halves, the foam material was torn off on both box stitch sections -square tack stitching.Both square tack stitches appeared to be stitched properly as they are intact with no evidence of workmanship issue.The strap was tied directly to the d-ring, and the knot tying on the d-ring is not the one that is specified on the ifu.Evaluation of the product found the box stitches joining the foam, wash label, and webbing containing the d-ring remained intact, and did not fail, but the failures of the product were in the foam.It appears that excessive force was applied by the patient causing the foam to tear apart.A review of the ifu and the failed areas of the product, found that the customer failed to follow the application instructions.Step 3a and 3b of bringing a loop of the connecting strap around the patient's wrist/ankle and bringing the end of the strap through the loop were not performed causing the foam to tear apart.Additionally, the ifu contraindications state to not use this device with someone who has continued highly aggressive or combative behavior, self-destructive behavior, or deemed to be an immediate risk to others or to self.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.The instructions for use (ifu) were reviewed, found to provide adequate instructions, warnings for safe and effective use of the device.No corrective, or preventative actions are necessary at this time.Manufacturer reference file (b)(4).

Event Description

Customer contacted us via e-mail.Lot is unknown.Gtin information not available.A ts template has been completed and saved to the drive.Customer states that a nurse caring for critical intubated patient heard banging of the patient's bed.Nurse found that patient had broken the left soft wrist holder, and was in the process of reaching his hand toward ett tube.New limb holder was applied, and patient was not successful with self extubation.There was no injury to patient, or team members.Follow up: this was the correct product for the patient population per the instructions for use.The correct device was used for the type of bed being used.We have been using posey limb holders for a long period of time.Applicable team members have received training on this product.The ifu was followed ensuring that the force is around the wrist, and not the foam of the product.The limb holder was correctly applied.The customer was large, and very strong.

• Brand Name: LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCT; 2530 lindsay privado drive; unit a; ontario CA 91761
• Manufacturer Contact: chris rahn ; 570 enterprise dr; neenah, WI 54956 ; 9207514300
• MDR Report Key: 10780002
• MDR Text Key: 214426608
• Report Number: 2020362-2020-00123
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2510
• Device Catalogue Number: 2510
• Device Lot Number: 0209T001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2020
• 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