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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC. FLUENT FLUID MANAGEMENT SYSTEM PROCEDURE KIT; INSUFFLATOR, HYSTEROSCOPIC
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HOLOGIC, INC. FLUENT FLUID MANAGEMENT SYSTEM PROCEDURE KIT; INSUFFLATOR, HYSTEROSCOPIC Back to Search Results
Model Number FLT-112S
Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 08/24/2021
Event Type  malfunction  
Event Description
Rn and scrub technician were putting together fluent system kit for surgeon to perform a procedure.Rn connected yellow fluent part to correct site.When rn went to prime the tubing system, the yellow fluent part popped off and the remaining pieces were loose underneath.Rn notified coordinator and vendor.They looked at set up and retrieved us new fluent tubing which worked.Fluent machine itself worked and recognized the issue.
 
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Brand Name
FLUENT FLUID MANAGEMENT SYSTEM PROCEDURE KIT
Type of Device
INSUFFLATOR, HYSTEROSCOPIC
Manufacturer (Section D)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
MDR Report Key12420975
MDR Text Key269771001
Report Number12420975
Device Sequence Number1
Product Code HIG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberFLT-112S
Device Catalogue NumberFLT-112S
Device Lot Number21F04R
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/26/2021
Event Location Hospital
Date Report to Manufacturer09/03/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age18250 DA
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