MAUDE Adverse Event Report: COVIDIEN 1 GA SHARPS CONTAINER; CONTAINER, SHARPS

Model Number 31143699

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2020

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 that 6 of the lids were not fitting.

• Brand Name: 1 GA SHARPS CONTAINER
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10053667
• MDR Text Key: 191716222
• Report Number: 1915484-2020-01167
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 40884521023124
• UDI-Public: 40884521023124
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2020

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: 31143699
• Device Catalogue Number: 31143699
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 05/13/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1