MAUDE Adverse Event Report: COVIDIEN MONOJECT 4 QT CT CONT - RED; CONTAINER, SHARPS

Model Number 8881676236

Device Problem Break (1069)

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 reports the tabs on the lid are breaking.There was no patient harm.

• Brand Name: MONOJECT 4 QT CT CONT - RED
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10927719
• MDR Text Key: 218940180
• Report Number: 1282497-2020-09694
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10884521018853
• UDI-Public: 10884521018853
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2020

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: 8881676236
• Device Catalogue Number: 8881676236
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/01/2020
• Type of Device Usage: N
• Patient Sequence Number: 1