MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER CLEAR AMBER SYRINGES; SYRINGE, PISTON

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

There is some ¿condensation¿ in the empty 20 ml baxter syringes.We contacted baxter and they stated that the syringes should be dry and to send them in for testing.The substances is an oily substance when touched, most likely a lubricant that is used during the manufacturing of the syringes.Due to potential infection control concerns, we sequestered these and all others with the same condensation and requested a new supply.Fda safety report id # (b)(4).

• Brand Name: BAXTER CLEAR AMBER SYRINGES
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 9489464
• MDR Text Key: 172228451
• Report Number: MW5091716
• Device Sequence Number: 2
• 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: 12/13/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1