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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION BAXTER CLEAR AMBER SYRINGES SYRINGE, PISTON Back to Search Results
Lot Number B301N261P
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).
 
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Brand NameBAXTER CLEAR AMBER SYRINGES
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key9489464
MDR Text Key172228451
Report NumberMW5091716
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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  
0 Patients were Involved in the Event:
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberB301N261P
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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