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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INDUSTRIES SDN. BHD. B. BRAUN EASYPUMP; PUMP, INFUSION, ELASTOMERIC

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B. BRAUN MEDICAL INDUSTRIES SDN. BHD. B. BRAUN EASYPUMP; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Lot Number 21M18GE671
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 02/08/2023
Event Type  malfunction  
Event Description
B.Braun easypump was found to have completely leaked all contents out of the side of the elastomeric.All clamps and caps were checked and verified for proper use/placement.
 
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Brand Name
B. BRAUN EASYPUMP
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
MDR Report Key16364412
MDR Text Key309511253
Report NumberMW5114886
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/08/2023
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 Lot Number21M18GE671
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/10/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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