MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC MONOJECT 60 ML SYRINGE CATHETER TIP; SYRINGE, IRRIGATING (NON DENTAL)

Model Number 1186000444

Device Problems Device Damaged Prior to Use (2284); Device Contamination with Chemical or Other Material (2944)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

Brand new syringe found with large piece of plastic inside the syringe in a sealed package.Looked to be damaged from the manufacturer.Risk closure comments: syringe and packaging saved.

• Brand Name: MONOJECT 60 ML SYRINGE CATHETER TIP
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 17343998
• MDR Text Key: 319228821
• Report Number: 17343998
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1186000444
• Device Catalogue Number: 1186000444
• Device Lot Number: 205927X
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1