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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 Problems Fail-Safe Problem (2936); Fail-Safe Did Not Operate (4046)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
After removing the product from the patient, the customer pulled up the arm, but the safety lock mechanism did not work.No patient injury.
 
Manufacturer Narrative
Investigation completed on smiths medical deltec grippers.The complaint of needle not retracting back into safety arm was not confirmed during testing of two samples.The engineering was reviewed and no malfunction during manufacturing.Device was within compliance at 100% prior to release.The complaint could not be confirmed.
 
Event Description
Investigation results completed and summary in h10.
 
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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 Key11391034
MDR Text Key233947524
Report Number3012307300-2021-01635
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586025594
UDI-Public10610586025594
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2021
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
Device Lot Number3971831
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2020
Was the Report Sent to FDA? No
Date Manufacturer Received04/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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