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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 21-7034-24
Device Problem Leak/Splash (1354)
Patient Problem Missed Dose (2561)
Event Date 07/14/2017
Event Type  malfunction  
Event Description
No medical intervention was required. No patient injury was reported.
 
Manufacturer Narrative
No device was returned for evaluation. Photos were returned for examination. Photographic inspection found two solvent bonds, with marks denoting the leak path. A review of the testing and inspection documents was performed and deemed adequate and correct. A review of the manufacturing process was performed on a similar part and found no discrepancies. Visual inspection of (b)(4) devices from the production floor was performed and found no discrepancies. Leak and pull testing was performed on (b)(4) samples from production and passed successfully. Based on the evidence, a root cause was unable to be determined.
 
Event Description
It was reported that the tubing of a cadd® administration set leaked during the patient's treatment. The patient went to the emergency room "for disconnect" and did not receive the drug. No permanent injury was 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 MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, 22425
MX 22425
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key6773812
MDR Text Key106182854
Report Number3012307300-2017-01724
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K895046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2021
Device Catalogue Number21-7034-24
Device Lot Number46X949
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/08/2017 Patient Sequence Number: 1
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