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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT LABORATORIES NEEDLELESS IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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ABBOTT LABORATORIES 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 NameNEEDLELESS IV CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ABBOTT LABORATORIES
MDR Report Key8503701
MDR Text Key141661885
Report NumberMW5085765
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 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
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/10/2019 Patient Sequence Number: 1
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