MAUDE Adverse Event Report: COVIDIEN 1 QT TRANSPORTABLE CONT; CONTAINER, SHARPS

Model Number 8303SA

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/14/2021

Event Type  Injury  

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 the sharps container used in the ems setting allowed for a needle to pierce the side of the container, causing an unprotected exposure/needle stick.Several attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.

• Brand Name: 1 QT TRANSPORTABLE CONT
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer (Section G): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11957369
• MDR Text Key: 254834773
• Report Number: 1424643-2021-00605
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10884521023666
• UDI-Public: 10884521023666
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8303SA
• Device Catalogue Number: 8303SA
• Device Lot Number: 20C11863
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other