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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY MINIBORE BIFUSE SET, ADMINISTRATION, INTRAVASCULAR

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BECTON DICKINSON AND COMPANY MINIBORE BIFUSE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Break (1069); Crack (1135); Fluid Leak (1250); Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
Numerous reports from various depts on multiple pts of iv fluids / meds leaking due to cracked tubing, broken maxzero caps resulting in wasted meds and time spent to troubleshoot. Y-site not disconnecting from tubing, unable to remove bifuse from cap, tip of bifuse broke off into maxzero cap, connection port of med line cracked, leak in medline tubing just above insertion point, bifuse tubing broken, tubing at the connection between iv fluid and manifold cracked, catheter tubing cracked / leaking at site attach to hub, leaking noted in the middle of iv tubing, fluid leaking at extension connection, numerous leaking at maxzero site. Defective products: minibore bifuse, alaris infusion tubing, maxzero cap, extension tubing, microbore extension tubing, microbore tubing extension needle free connector, nonvented blood tubing, alaris pump module no filter, extension tubing, alaris pump module with filter.
 
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Brand NameMINIBORE BIFUSE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
franklin lakes NJ
MDR Report Key7762408
MDR Text Key116600352
Report NumberMW5078932
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/31/2018
10 Devices were Involved in the Event: 1   2   3   4   5   6   7   8   9   10  
0 Patients were Involved in the Event:
Date FDA Received08/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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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