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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® CADD® EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD® CADD® EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7106-24
Device Problem Fluid Leak (1250)
Patient Problems Fatigue (1849); Rash (2033); Complaint, Ill-Defined (2331)
Event Date 03/26/2018
Event Type  malfunction  
Event Description
Information was received indicating that this extension set exhibited leakage. The medication that was being infused leaked onto the patient's skin and resulted in a rash on the skin. The patient also noted that they felt poorly and were more fatigued with decreased energy and an increased need for oxygen. No adverse patient effects were reported.
 
Manufacturer Narrative
Nine samples were returned for analysis in used condition inside a plastic bag with their original open packaging. Visual inspection of the samples showed delamination in the joints of the filter with the tube. Functional testing included leak testing. Leak testing on all the samples received were performed using hydrostat vessel to look for unusual functions; a leak was observed fleeing from the air vent of the filter in seven of the samples. A review of the manufacturing process was performed in order to verify that there are no situations or practices that could cause or contribute to the field observation, no discrepancies were found. Based on the evidence, the complaint was confirmed. The root cause of the leak was attributed to either the filter being sent by the supplier in defective conditions or the filter becoming damaged after leaving the manufacturer.
 
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Brand NameCADD® CADD® EXTENSION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7519953
MDR Text Key108493261
Report Number3012307300-2018-01764
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7106-24
Device Lot Number57X488
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/30/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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