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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD 250 ML MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD 250 ML MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2020
Event Type  malfunction  
Event Description
It was reported that during a pre-use check, the customer found a kink in the tubing on the pressure plate. No patient injury was reported.
 
Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture. The product sample was received for evaluation visual and functional testing were performed. Two pictures were attached. One picture shows a cassette product out of its original packaging. Picture two shows a kink in the extension tube of the cassette. The one sample received with its original packaging inside in a plastic bag. The sample received presented a kink in the extension tube. The most probably root cause is that the extension tube with kinks were not detected by production personnel during the assembly process.
 
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Brand NameCADD 250 ML MEDICATION CASSETTE RESERVOIR
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
jim vegel
6000 nathan lane north
akasaka, minato-ku, tokyo
minneapolis, MN 55442
MDR Report Key14314002
MDR Text Key291215005
Report Number3012307300-2022-07914
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027239
UDI-Public10610586027239
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040636
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
Report Date 05/26/2022
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 Number21-7302-24
Device Catalogue Number21-7302-24
Device Lot Number3971709
Was Device Available for Evaluation? No
Date Returned to Manufacturer01/06/2021
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 Manufactured06/13/2020
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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