MAUDE Adverse Event Report: POSEY PRODUCTS UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF; RESTRAINT, PROTECTIVE

Model Number 2700Q

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

Product is scheduled to be returned but has not been received in by manufacturer at the time of this report.Therefore, this report is based solely on the information provided by the customer.Ifu states that before each use, check cuffs and straps for cracks, tears, and/or excessive wear or stretch, cracked or broken buckles or locks, and/or that hook-and-loop adheres securely, as these may allow patient to remove cuff.Discard if device is damaged.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 warning 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.(b)(4).Product not returned.

Event Description

On 08-10-2021 (b)(6) the customer contacted us via e-mail.The customer states" please see the below information from (b)(6) security regarding an issue they are reporting with the posey restraint cuff blue regular.Can you please start a qi and work with (b)(6) to gather any additional information you may need? please include the defective tracking team in any correspondence for the tracking/documentation.This report's unique identifier is (b)(4) should you need to reference it.Report date: (b)(6) 2021 campus: (b)(6) department: security manufacturer: posey product name: restraint cuff blue regular product description: restraint cuff blue regular manufacturer product number: 2700q lot number: 0335t039 date of event: (b)(6) 2021 description of defect: buckle broke on restraint used on patient: yes is product available for testing: yes location of product: security office at (b)(6) contact: (b)(6)" the customer would like to return it for testing and warranty consideration.No gtin information was provided.

Manufacturer Narrative

H3: evaluation summary.Product returned for evaluation was only a single restraint.Visual findings observed one of the prongs on the 3 point bed connecting male buckle (h1918) is broken.Evaluation of the product found one of the male prongs of the bed connecting three point buckle is broken (h1918).The broken prong was not returned.The alignment rails inside the bed connecting female buckle are broken.No void observed on the prong broken area that would suggest a manufacturing process issue.If the buckle(s) pre-releases or is backwards, it may allow the buckle to initially close, but it is possible that the buckle could later unlatch while in use.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 warning 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 warrant manufacturer reference file (b)(4).

Event Description

Supplemental medwatch being sent for additional information.

• Brand Name: UNIVERSAL TWICE-AS-TOUGH QUICK RELEASE CUFF
• Type of Device: RESTRAINT, PROTECTIVE
• Manufacturer (Section D): POSEY PRODUCTS; 2530 lindsay privado drive; unit a; ontario CA 91761
• MDR Report Key: 12447585
• MDR Text Key: 281016278
• Report Number: 2020362-2021-00056
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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: 2700Q
• Device Catalogue Number: 2700Q
• Device Lot Number: 0335T039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1