MAUDE Adverse Event Report: IL081 IL-CRYSTAL LAKE 8 GA RENEWABLES SLIDE LID; CONTAINER, SHARPS

Model Number 8980S

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that they cannot open/close the sliding lid of the sharps container.

Manufacturer Narrative

A review of the device history record (dhr) was completed for the reported lot number.The dhr review concluded no abnormal process conditions were present during the manufacturing of this product that would lead to the reported condition.The dhr review also showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Five samples of the lid assembly were received for evaluation.It was confirmed that the lid was not assembled correctly with the slide top 180 degrees rotated from the proper orientation precluding the final locking mechanism feature.The root cause analysis determined that the most likely root cause was human error; the operator erroneously placing the door on the lid in the incorrect orientation as designated.Mitigations including in-process inspections and standard works are in place to mitigate occurrences of this failure.Based on the information available and the investigation findings additional actions are not deemed necessary at this time.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 8 GA RENEWABLES SLIDE LID
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): IL081 IL-CRYSTAL LAKE; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 10242566
• MDR Text Key: 198124632
• Report Number: 1424643-2020-00579
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 30884521022489
• UDI-Public: 30884521022489
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

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: 8980S
• Device Catalogue Number: 8980S
• Device Lot Number: 19G12763
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 10/07/2020
• Patient Sequence Number: 1