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

Model Number 2794

Device Problems Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)

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.While investigating a separate complaint, a potential link to this complaint was identified due to the associated part numbers (2794 & s27947).The troubleshooting form for this complaint was reviewed on (b)(6) 2020.The text at the bottom of the form revealed more detail about the complaint, originally left out of the complaint description received by quality.The text reads "unit reported as being able to detach itself".If the device detaches on its own, it could allow unintentional patient release.This could result in the patient injuring self or others and is therefore mdr reportable.A review of manufacturing documentation could not be performed since there was no serial/lot number provided for this device.Historical complaint data review revealed the aforementioned similar complaint against a related product.There appears to be an increasing trend of this complaint for this product type.Further investigation is underway.Appropriate corrective action will be taken based on risk assessment.The instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.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.(b)(4).

Event Description

Received email regarding a defective restraint.Chs is still in the process of gathering photos and lot number confirmation.Troubleshooting guide saved, no gtin provided.

Manufacturer Narrative

H3: device received and evaluated.Qa evaluation found no manufacturing or functional defects.Engineering evaluation confirmed no detectable defects during simulated use.A few minor cosmetic observations were noted, but none that would contribute to the device being able to detach itself.Since no device design or manufacturing defect could be confirmed, the probable causes of the complaint could be improper application of the device.This failure mode is already captured within device risk files.A historical complaint review was performed for related failure modes for this device.Several other related skus were also included in the historical review that have similar design and functional features and failure modes.Most complaints were related to the d-ring feature.Return sample evaluation identified no damage to the d-ring or slippage during simulated use.Therefore, these complaints may not be related to this specific failure mode.There were 3 reported events in 2018 and 2019 that could be related to this issue of device able to detach itself due to improper application.Since no device design or manufacturing defect could be confirmed, the probable cause of the complaint is improper application of the device.This failure mode is already captured within the risk file.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 reference file no 2020-00636.

Event Description

While investigating a separate complaint, a potential link to this complaint was identified due to the associated part numbers (2794 & s27947).The troubleshooting form for this complaint was reviewed on july 22, 2020.The text at the bottom of the form revealed more detail about the complaint, originally left out of the complaint description that was received by quality on june 2, 2020.The text reads.Unit reported as being able to detach itself.

• Brand Name: CONNECTED TWICE-AS-TOUGH CUFFS
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS LLC; 570 enterprise dr; neenah WI 54956
• MDR Report Key: 10310269
• MDR Text Key: 199986438
• Report Number: 2020362-2020-00097
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2794
• Device Catalogue Number: 2794
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1