MAUDE Adverse Event Report: COVIDIEN LLC MONOJECT LIFESHIELD; NEEDLE, HYPODERMIC

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2019

Event Type  malfunction  

Event Description

Covidien monoject 1ml tuberculin safety syringe with needle, 28g x 1/2" in a sealed package.Nurse observed that needle was bent (able to see it while in the sealed package).The needle was not used on a patient.Device is available for return to the manufacturer.

• Brand Name: MONOJECT LIFESHIELD
• Type of Device: NEEDLE, HYPODERMIC
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9238700
• MDR Text Key: 163767646
• Report Number: 9238700
• Device Sequence Number: 1
• Product Code: NKK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1