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

Model Number	31144010
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported the lids of the sharps safety containers were already snapped shut.
Additional 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
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 10542290
• Report Number: 1424643-2020-00583
• Device Sequence Number: 3123839
• Product Code: MMK
• UDI-Device Identifier: 10884521022997
• UDI-Public: 10884521022997
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 31144010
• Device Catalogue Number: 31144010
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 09/03/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1