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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL CADD EXTENSION SET INTRAVENOUS EXTENSION TUBING SET

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SMITHS MEDICAL ASD, INC. SMITHS MEDICAL CADD EXTENSION SET INTRAVENOUS EXTENSION TUBING SET Back to Search Results
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2020
Event Type  malfunction  
Manufacturer Narrative
Mw5092701.
 
Event Description
Information was received that a smiths medical cadd extension set gets twisted and disconnects. It takes several attempts to connect correctly. Patient did switch to a different tubing set to continue infusion. The incident did not occur while in use with a patient, and was reported to be resolved. Remodulin was being infused at 2 mg/ ml. No patient injury.
 
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Brand NameSMITHS MEDICAL CADD EXTENSION SET
Type of DeviceINTRAVENOUS EXTENSION TUBING SET
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane n
minneapolis, mn
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis, mn 
MDR Report Key9862033
MDR Text Key186313654
Report Number3012307300-2020-02071
Device Sequence Number1
Product Code OJA
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 company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 03/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2020
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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