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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 21-2766-24
Device Problem Use of Device Problem (1670)
Patient Problem Needle Stick/Puncture (2462)
Event Date 04/01/2020
Event Type  malfunction  
Event Description
Information was received indicating that needle stick occurred with use of a smiths medical deltec gripper plus safety needle.It was reported that the safety arm would not lock, and the needle sprung out of it.There were no reported adverse effects.
 
Manufacturer Narrative
Returned device was received for evaluation.During the evaluation of the device we observed that safety mechanism was already activated, and the needle was out of the base.The customer reported condition was confirmed.Problem source is unknown.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
DELTEC
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10074550
MDR Text Key191548165
Report Number3012307300-2020-04599
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586025594
UDI-Public10610586025594
Combination Product (y/n)N
PMA/PMN Number
K021999
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number21-2766-24
Device Catalogue Number21-2766-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2020
Was the Report Sent to FDA? No
Date Manufacturer Received09/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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