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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL

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B. BRAUN MEDICAL, INC. IRRIGATION SET; SYSTEM, IRRIGATION, UROLOGICAL Back to Search Results
Model Number 313003
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/14/2018
Event Type  malfunction  
Event Description
The drip chamber of the tubing for the continuous bladder irrigation was found to have a slow leak - the tubing was changed to new device without issue.
 
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Brand Name
IRRIGATION SET
Type of Device
SYSTEM, IRRIGATION, UROLOGICAL
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
901 marcon blvd
allentown PA 18109
MDR Report Key7633439
MDR Text Key112184465
Report Number7633439
Device Sequence Number1
Product Code LJH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/20/2018
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 No Information
Device Model Number313003
Device Catalogue Number313003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Device Age1 DY
Date Report to Manufacturer06/25/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/25/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age26645 DA
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