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U.S. Department of Health and Human Services

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

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B. BRAUN MEDICAL INDUSTRIES SDN. BHD. EASYPUMP; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Model Number II LT 270-27-S
Device Problem Leak/Splash (1354)
Patient Problem Insufficient Information (4580)
Event Date 01/25/2023
Event Type  malfunction  
Event Description
Easypump 270/10 began leaking as technician was compounding.Discarded and made a new one.
 
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Brand Name
EASYPUMP
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
B. BRAUN MEDICAL INDUSTRIES SDN. BHD.
MDR Report Key16363542
MDR Text Key309515897
Report NumberMW5114877
Device Sequence Number1
Product Code MEB
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 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 Model NumberII LT 270-27-S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/10/2023
Patient Sequence Number1
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