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U.S. Department of Health and Human Services

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

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ST PAUL CADD EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7106-24
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2021
Event Type  malfunction  
Event Description
It was reported that during the pre-use check the tube was partially kinked. No patient injury was reported.
 
Manufacturer Narrative
One device was returned for evaluation. Visual inspection of the returned device and review of the provided photos found the luer and filter were bent and damaged. Based on the analysis the reported event is confirmed. The most probable root cause is that the device became damaged after manufacture as the components are 100% visual inspected prior to release. A dhr was conducted which indicated all inspections were completed and no issues were noted during manufacture.
 
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Brand NameCADD EXTENSION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
jim vegel
6000 nathan lane north
akasaka, minato-ku, tokyo
minneapolis, MN 55442
MDR Report Key14321906
MDR Text Key291210861
Report Number3012307300-2022-08061
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586023279
UDI-Public10610586023279
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,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 06/08/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number21-7106-24
Device Catalogue Number21-7106-24
Device Lot Number3905424
Was Device Available for Evaluation? No
Date Returned to Manufacturer02/10/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-0148-2022

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