MAUDE Adverse Event Report: POSEY PRODUCTS, LLC CONNECTED TWICE-AS-TOUGH CUFFS; RESTRAINT, PROTECTIVE

Model Number S27947

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device return expected, but not yet received for evaluation.Therefore, this report is based on customer provided information only.If the device does not secure as intended and detaches on its own, it could allow unintentional patient release.This could result in the patient injuring self or others.A review of manufacturing documentation could not be performed since there was no serial/lot number provided for this device.Historical complaint data review did not find any other complaints for these devices not being secure or detaching on their own.There does not appear to be an increasing trend of this complaint for this product type.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 file number: (b)(4).Device expected, but not yet received.

Event Description

Chs representative reported via email that the product was not secure and able to detach by itself.Requested more details due to limited information provided.

Manufacturer Narrative

H3: despite attempts, the device was not returned for evaluation.A potential trend was identified for this failure mode due to associated part numbers and similar complaint descriptions.An internal investigation was launched to further investigate the issue and determine associated risk.The device associated with this complaint was not received for evaluation, therefore this report is based solely on the findings of that investigation and historical complaint data review.Based on the inspection completed on the samples that were returned for similar failure, no manufacturing or functional defects were identified.A few minor cosmetic observations were noted, but none that would contribute to the device being able to detach itself.A historical complaint review was performed for related failure modes for the associated part numbers, along with several other related products that have similar design and functional features and failure modes.The majority of the reported events are related to the d-ring feature.Per the return samples evaluated, no observations were noted regarding damage to the d-ring or slippage during simulated use.Therefore, these complaints may not be related to this specific issue.There were three reported events in 2018 and 2019 for the restraint releasing when pulled by the patient.This failure mode could be related to this issue of device able to detach itself due to improper application or user error.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.The risk file review also indicated this failure mode is already captured and the device is operating within its risk profile.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 file number: (b)(4).

Event Description

Megha reported via email that the product was not secure and able to detach by itself.Requesting more details due to limited info provided.Chs# (b)(4).

• Brand Name: CONNECTED TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS, LLC; 570 enterprise drive; neenah WI 54956
• MDR Report Key: 10298700
• MDR Text Key: 201879144
• Report Number: 2020362-2020-00091
• Device Sequence Number: 1
• Product Code: FMQ
• Combination Product (y/n): N
• PMA/PMN Number: K963413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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: No Information
• Device Model Number: S27947
• Device Catalogue Number: S27947
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1