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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number AMC9668
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2024
Event Type  malfunction  
Event Description
It was reported that a continu-flo solution set separated "from the distal part".The event occurred during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
CONTINU-FLO SOLUTION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MALTA
a47 industrial estate
marsa
MT  
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key19209301
MDR Text Key341484555
Report Number1416980-2024-01966
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05413765578038
UDI-Public(01)05413765578038
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberAMC9668
Device Lot Number23G05V240
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2024
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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