MAUDE Adverse Event Report: SOLUTIONS, INC. 3-GALLON MOUNTED WALL ENCLOSURE SHARPS CONTAINER; CONTAINER, SHARPS

Model Number 1331

Device Problems Product Quality Problem (1506); Structural Problem (2506); Fail-Safe Did Not Operate (4046)

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

Event Date 10/19/2022

Event Type  malfunction  

Event Description

Patient was able to unlock the sharps container wall mount with a spoon and very little effort and then able to shake dirty needles and vials from the sharps container.Upon further investigation, it was easy for nursing to open all the wall mounts without keys due to the looseness of the door hingers.This is a danger to our patients and our staff if violent patients can obtain dirty sharps.Fda safety report id# (b)(4).

• Brand Name: 3-GALLON MOUNTED WALL ENCLOSURE SHARPS CONTAINER
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): SOLUTIONS, INC.; jeffersonville IN
• MDR Report Key: 15806245
• MDR Text Key: 303825077
• Report Number: MW5113289
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/11/2022

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: Health Professional
• Device Model Number: 1331
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White