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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7383-24
Device Problem Partial Blockage (1065)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Foreign source: (b)(6).
 
Event Description
Information was received indicating that after approximately four to six hours of total parenteral nutrition with a smiths medical cadd administration set with air-eliminating filter, an air bubble was observed.No adverse patient effects were reported.
 
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Brand Name
CADD ADMINISTRATION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. .
ave calidad no. 4,
parque industrialinternacional
tijuana, 22425
MX   22425
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key9204198
MDR Text Key165455576
Report Number3012307300-2019-05696
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027475
UDI-Public10610586027475
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number21-7383-24
Was Device Available for Evaluation? No
Date Manufacturer Received09/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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