MAUDE Adverse Event Report: COVIDIEN 5 QT TP SHARPS CONT -TRANS RED; CONTAINER, SHARPS

Model Number 31144010

Device Problem Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2020

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.

Event Description

The customer reported the lids of the sharps safety containers were already snapped shut.

Manufacturer Narrative

The device history record (dhr) was not reviewed as there was no lot number provided however, a lot will not be released unless all criteria has been met.The sample was received for evaluation and was visually inspected.The reported issue was observed; all 8 lids were in the final locking position.The probability that the issue occurred during the assembly process is unlikely as the issue would have been visible during the inspection process.Instructions for use are provided with this product; however, it is possible that the user may not have operated the lid according to the instructions.This can occur if third party distributors break down the product from the original unit of measure and repackage the product inadvertently or mistakenly engaged the final lock during repackaging.An adverse trend has not been identified and this complaint will be retained and used for trending purposes.

• Brand Name: 5 QT TP SHARPS CONT -TRANS RED
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 10542290
• MDR Text Key: 207335155
• Report Number: 1424643-2020-00583
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10884521022997
• UDI-Public: 10884521022997
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

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: 31144010
• Device Catalogue Number: 31144010
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 10/28/2020
• Patient Sequence Number: 1