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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. NEEDLELESS IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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B. BRAUN MEDICAL, INC. NEEDLELESS IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Microbial Contamination of Device (2303)
Patient Problems Death (1802); Unspecified Infection (1930)
Event Type  Death  
Event Description
Central line associated blood stream infection attributable to unprotected, needleless iv connector contamination.Needleless iv connector diaphragms are not protected against accidental touch, which results in accidental contamination, biofilm formation, and then line infection.The cdc attributes 10,000 deaths of american pts to these line infections, also called central line associated blood stream infections (clabsi).These 10,000 severe adverse events (each year) are herewith reported to the fda.The fda will otherwise never become aware of these severe adverse events due to the defective device unprotected needleless connector, because healthcare providers and their institution will not indict themselves (dr, did you have bad hygienic habits?) or risk penalties for poor infection control.
 
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Brand Name
NEEDLELESS IV CONNECTOR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
B. BRAUN MEDICAL, INC.
MDR Report Key8503701
MDR Text Key141661885
Report NumberMW5085765
Device Sequence Number2
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 Physician
Type of Report Initial
Report Date 03/31/2019
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received04/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Life Threatening; Required Intervention;
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