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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD HIGH VOLUME ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD HIGH VOLUME ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7381-24
Device Problems Detachment Of Device Component (1104); Fluid Leak (1250); Connection Problem (2900); Fail-Safe Problem (2936); No Fail-Safe Mechanism (2990)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/03/2018
Event Type  Injury  
Event Description
I have experienced possibly life threatening problems with the following smiths medical cadd high volume administration sets ref 21-7381-24, lot 3560191, exp date 02/27/2023. The problem encountered is that the male luer connector is easily detached from the tubing. Shortly after beginning my nightly infusion, i noticed i was getting wet. Looking down, i saw that the tubing had literally fallen out of the male luer connector. This resulted in iv fluid (tpn) being dispensed onto my clothing, and most importantly, resulted in my central line port being now wide open to the environment and could freely aspirate blood out of or ingest room air into my body. I see a high probably of air embolism, bleeding out and/or bloodstream infection (sepsis) resulting from this failure. I tested add'l administration sets from the same lot and found that the male luer disconnects from the tubing with only a sight pull. Had this happened while i was asleep and gone unnoticed. I believe it could have easily been life threatening. I have used this product for over eight years and have never seen anything like this.
 
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Brand NameCADD HIGH VOLUME ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key7493916
MDR Text Key107791816
Report NumberMW5077036
Device Sequence Number0
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 Unknown
Type of Report Initial
Report Date 05/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2018
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7381-24
Device Lot Number3560191
Was Device Available for Evaluation? Yes
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

Patient Treatment Data
Date Received: 05/07/2018 Patient Sequence Number: 1
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