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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
Model Number 21-7106-24
Device Problems Break (1069); Fluid Leak (1250); Insufficient Flow or Under Infusion (2182)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 11/13/2019
Event Type  malfunction  
Manufacturer Narrative
Report source: (b)(6).
 
Event Description
Information was received indicating that during use a smiths medical cadd extension set was leaking and it was noticed that the tube was "partially torn. " per reporter the patient did not receive medication for approximately ten (10) hours and felt ill due to side effects when the set was replaced and administration was resumed. No additional adverse effects were reported.
 
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Brand NameCADD ADMINISTRATION SET
Type of DeviceSET, 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 Key9481769
MDR Text Key176032874
Report Number3012307300-2019-07148
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7106-24
Device Catalogue Number21-7106-24
Device Lot Number3717786
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/14/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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