MAUDE Adverse Event Report: COVIDIEN MONOJECT; 1 ML TUBERCULIN SAFETY SYRINGE

Model Number REF 8881511201

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2019

Event Type  malfunction  

Event Description

Lpn administered ppd using covidien monoject 1ml tuberculin safety syringe lot 631950x.The needle safety did not engage after use.Nurse was able to slide safety shield back and forth over needle several times without force, lock did not engage.Needle was disposed of in a sharps container to prevent accidental needlestick with a dirty needle.No injury occurred as a result.The purpose of this report is to make aware of a potential issue with this lot.

• Brand Name: MONOJECT
• Type of Device: 1 ML TUBERCULIN SAFETY SYRINGE
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 8400938
• MDR Text Key: 138278074
• Report Number: 8400938
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: REF 8881511201
• Device Lot Number: 631950X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2019
• Event Location: Nursing Home
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1