MAUDE Adverse Event Report: TIDI PRODUCTS LLC LIMB HOLDER; RESTRAINT, PROTECTIVE

Model Number 2551

Device Problem Device Slipped (1584)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

H3: product is scheduled to be returned but has not been received by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.A territory manager of posey products confirmed the patient partially extubated self, but staff was able to get the trach back in place with no injury.Additionally, she noted the overhand knot prescribed in the instructions for use was not applied at time of incident.Customer stated they have not been using this method when applying the restraint and had not seen the product slip as it did in this instance.The instructions for use application instructions state.Insert the male end of the connecting strap into the female end of the short strap.Listen for a snapping sound.Pull firmly on the straps to ensure a good connection.To limit unwanted adjustment, tie an overhand knot with the excess strap directly below the quick-release buckle.Contraindications in the ifu state do 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.Based on the report, the instructions for use were not followed for this incident.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 is reporting a complaint on product (b)(4).Customer states that male end of the clip connecting the long strap to the female end of the buckle on the attachment loop is not holding.There was a near miss with a patient event.Patient was able to extubate themselves as a result of the restraint not holding.

Event Description

Supplemental medwatch being sent for additional information.

Manufacturer Narrative

Evaluation of returned product found only a single foam limb holder was received, normally sold in pairs.When the application instructions in the ifu were followed, the restraints did not exhibit slippage issue indicating the product is functional and will perform as intended.However, if the ifu step 1b.Was not followed where the overhand knot with the excess strap was not present to limit unwanted adjustment, the bed connecting strap exhibited slippage due to the male buckle.Possible root cause for this deficiency is that the ifu was not followed while applying this restraint.A review of the complaint database revealed ten similar events against this device in the past two years leading tidi to redesign the male buckle of the product to mitigate the slipping issue from occurring while the knot is not present.The issue is being addressed via corrective action.The instructions for use application instructions state.Insert the male end of the connecting strap into the female end of the short strap.Listen for a snapping sound.Pull firmly on the straps to ensure a good connection.To limit unwanted adjustment, tie an overhand knot with the excess strap directly below the quick-release buckle.Contraindications in the ifu state do 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.Based on the report, the instructions for use were not followed for this incident.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).

• Brand Name: LIMB HOLDER
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): TIDI PRODUCTS LLC; 570 enterprise drive; neenah WI 54956
• Manufacturer Contact: chris rahn ; 570 enterprise drive; neenah, WI 54956 ; 9207514300
• MDR Report Key: 18162038
• MDR Text Key: 328643274
• Report Number: 2182318-2023-00109
• Device Sequence Number: 1
• Product Code: FMQ
• UDI-Device Identifier: 10190676004956
• UDI-Public: 10190676004956
• 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,Followup
• Report Date: 11/30/2023

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 Model Number: 2551
• Device Catalogue Number: 2551
• Device Lot Number: 3180T128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 11/30/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• 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