MAUDE Adverse Event Report: COVIDIEN / CARDINAL HEALTH MONOJECT 6 ML PHARMACY TRAY OF SYRINGES; SYRINGE, PISTON

Catalog Number 8881516200

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2022

Event Type  malfunction  

Event Description

Package of multi unit sterile empty syringes opened and found a machine set screw inside.Fda safety report id #:(b)(4).

• Brand Name: MONOJECT 6 ML PHARMACY TRAY OF SYRINGES
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN / CARDINAL HEALTH
• MDR Report Key: 13863493
• MDR Text Key: 287846595
• Report Number: MW5108467
• 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: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8881516200
• Device Lot Number: 2002112264
• 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