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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7391-24
Device Problems Material Fragmentation (1261); Mechanical Problem (1384)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/08/2020
Event Type  Injury  
Event Description
Information was received indicating that a smiths medical cadd administration set was noted to have the line threaded through the side clamp and was unable to be rectified. The reporter indicated that the needle and introducer were inspected prior to insertion, needle was inserted into patient's lower back, then the needle was slowly withdrawn then a sudden loss of resistance was felt and only half of needle came out of the patient, other half broke off inside patients back on removal. The reporter indicated that neurologist came in and performed operation to remove remaining needle. No further adverse effects were reported.
 
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Brand NameCADD ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10111466
MDR Text Key193411965
Report Number3012307300-2020-05428
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7391-24
Device Catalogue Number21-7391-24
Device Lot Number3823334
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/02/2020 Patient Sequence Number: 1
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