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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD

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SMITHS MEDICAL ASD, INC. CADD Back to Search Results
Device Problem Material Fragmentation (1261)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/27/2019
Event Type  malfunction  
Manufacturer Narrative
Four cadd cleo infusion sets were returned for analysis. The samples were visually inspected, at a distance of 12? to 24? and normal conditions of illumination. The cannula was found to be broken in one of the samples. A review of the manufacturing process was conducted and all the procedures were found to be followed properly. Functional tests were also performed. Three samples were taken from the cleo production line and tested; after removing the white cap the site was inserted into the insertion pad. No detachment was detected in any of the tested samples and the cannula was not removed from the site. The retractor assemblies are 100% visually inspected by the production personnel to assure that the needle is properly threaded. Quality control performs an in-process audit at 1-hour intervals to verify that needle is properly threaded on the retractor assemblies. Device history review: part number
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21-7230-24. Lot number
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78x094. Quantity released
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(b)(4) units. Manufacturing date
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january 2018. Idr, dmr, or da
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none per review of the dhr. Part number
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21-7230-24. Lot number
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76x099. Quantity released
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(b)(4) units. Manufacturing date
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june 2016. Idr, dmr, or da
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none per review of the dhr. Part number
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21-7230-24. Lot number
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77x094. Quantity released
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(b)(4). Manufacturing date
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july 2017. Idr, dmr, or da
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none per review of the dhr. Part number
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21-7230-24. Lot number
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77x143. Quantity released
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(b)(4). Manufacturing date
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september 2017. Idr, dmr, or da
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none per review of the dhr.
 
Event Description
Information was received indicating that the cannula remained in the patient's body after using the cadd cleo infusion set. After the patient removed the device from the abdomen site, it was noticed that the cannula was not attached. Ultra sound results were inconclusive and a ct scan was then recommended. The patient decided to not proceed with it and to simply ?wait and see".
 
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Brand NameCADD
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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10121871
MDR Text Key194109227
Report Number3012307300-2020-05500
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2020
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/27/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/05/2020 Patient Sequence Number: 1
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