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

Model Number 31G

Device Problems Delivered as Unsterile Product (1421); Failure to Deliver (2338); Dull, Blunt (2407)

Patient Problems Eye Injury (1845); Unspecified Infection (1930)

Event Date 05/02/2019

Event Type  Injury  

Event Description

Infection and ophthalmic injury from device.Compounded syringe needle was dull.Plunger unable to express product.Resulted in infection.Currently awaiting sensitivity results.Feel that this is not a sterile product and syringe isn't a proper delivery device.Outside room air can be drawn into the syringe and contaminate product since the plunger can freely move during shipping.The device should be individually sealed so that plunger can't move and draw in bacteria.Current package isn't sterile.The outside of the syringe should be sterile has fingerprints on it, so common bacteria can easily enter the product.When we contacted the mfr, they said they don't make this drug in syringes.(b)(6) in (b)(6) is the compounding mfr.Awaiting results.Fda safety report id# (b)(4).

• Brand Name: MONOJECT SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; melbourne FL
• MDR Report Key: 8599820
• MDR Text Key: 144841873
• Report Number: MW5086525
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 31G
• Device Lot Number: NO LOT NUMBER ON SYRINGE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 72 YR
• Patient Weight: 90