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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
Medical Device Problem Codes Fail-Safe Problem (2936); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/2021
Type of Reportable Event Malfunction
Event or Problem 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.
 
Additional 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 or Problem Description
Investigation results completed and summary in h10.
 
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Brand Name
DELTEC
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11391034
Report Number3012307300-2021-01635
Device Sequence Number1167248
Product Code FPA
UDI-Device Identifier10610586025594
UDI-Public10610586025594
Combination Product (Y/N)N
Initial Reporter CountryJA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date05/20/2025
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
Initial Date Received by Manufacturer 01/29/2021
Supplement Date Received by Manufacturer04/04/2021
Initial Report FDA Received Date02/28/2021
Supplement Report FDA Received Date05/03/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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