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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN ADDEASE SET IV FLUID

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B. BRAUN ADDEASE SET IV FLUID Back to Search Results
Device Problems Bag (553); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  No Answer Provided  
Event Description

Normally our pharmacy prepares 3. 375 gm piperacillin/tazobactam by connecting the vial using addease connectors to a 50ml bbraun d5w bag. This connected product is stored in the adm and readily available for the nurse to activate prior to administration. Due to a shortage in bbraun 50 ml iv d5w bags and not to delay therapy to patients, our pharmacy prepared piperacillin/tazobactam by addeasing it to a baxter 50ml d5w bag, which was available. Unfortunately, the addease product connects to the baxter bag, however this connection is not secure and the vial detaches from bag during activation. (b)(4).

 
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Brand NameADDEASE
Type of DeviceSET IV FLUID
Manufacturer (Section D)
B. BRAUN
MDR Report Key6784832
MDR Text Key82566930
Report NumberMW5071468
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/21/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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