MAUDE Adverse Event Report: COVIDIEN 60 ML MONOJECT SYRINGE; SYRINGE, PISTON

Model Number 1186000777

Device Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2022

Event Type  malfunction  

Event Description

Some 60 ml syringes have a bent tip making it difficult to correctly attach a needle to the syringe.It is also not possible to remove the needle once attached.Fda safety report id# (b)(4).

• Brand Name: 60 ML MONOJECT SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 13453811
• MDR Text Key: 285220778
• Report Number: MW5107200
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1186000777
• Device Catalogue Number: 1186000777
• Device Lot Number: 131967X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1