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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL DELTEC INTRAVASCULAR ADMINISTRATION SET

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ST PAUL DELTEC INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 21-2766-24
Device Problem Fail-Safe Problem (2936)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  malfunction  
Event Description
It was reported that after the use of the product, a click sound was heard when the customer pulled up the safety arm. The needle was not successfully locked and the safety mechanism was found broken. No patient injury. No additional information is available for this complaint.
 
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Brand NameDELTEC
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
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
aichi pref.
minneapolis, MN 55442
MDR Report Key12380842
MDR Text Key268645950
Report Number3012307300-2021-08935
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 08/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-2766-24
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 Received07/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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