MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MONOJECT SYRINGE; SYRINGE, IRRIGATING (NON DENTAL)

Model Number H93867031

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

Monoject 60ml cardinal health manufacturer: cardinal health ref # (b)(4) lot# 220401 and 220402 (both lots on pvt where the leaks have been reported) exp: 03/31/2027 with manufacturer: baxter ref # (b)(4) lot# 60349214 exp: 01/31/2025 leaks after pharmacy preparation in this syringe product from china.Reference reports: mw5152283, mw5152284.

• Brand Name: MONOJECT SYRINGE
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 18828301
• MDR Text Key: 336961590
• Report Number: MW5152285
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: H93867031
• Device Lot Number: 60349214
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1