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U.S. Department of Health and Human Services

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

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ST PAUL DELTEC SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-2767-24
Device Problem Fail-Safe Problem (2936)
Patient Problem Needle Stick/Puncture (2462)
Event Date 03/08/2021
Event Type  malfunction  
Event Description
It was reported that the nurse was de-accessing the patient's port-a-cath following chemotherapy treatment. Upon pulling up on the non-coring needle, the needle did not lock into the safety guard, but instead pulled up beyond the safety guard. This ended up nicking the nurse's finger. No visual abnormalities were noted with the device prior to, during use, or at time when the nurse was preparing to de-access. Following the incident, the nurse visited visit the occupational health department at the facility. No medical intervention was required to address the incident.
 
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Brand NameDELTEC
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
suite 1700
minneapolis, MN 55442
MDR Report Key11663660
MDR Text Key245326333
Report Number3012307300-2021-03100
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 04/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-2767-24
Device Catalogue Number21-2767-24
Device Lot Number4060762
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 Received03/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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