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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DELTEC; SET, ADMINISTRATION, INTRAVASCULAR,
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DELTEC; SET, ADMINISTRATION, INTRAVASCULAR, Back to Search Results
Model Number 21-2966-24
Medical Device Problem Code Infusion or Flow Problem (2964)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/15/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported the device was in use with patient and device showed air in the tubing.No adverse effects reported.
 
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Brand Name
DELTEC
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR,
MDR Report Key11649272
Report Number3012307300-2021-03068
Device Sequence Number3356617
Product Code FPA
UDI-Device Identifier10610586027741
UDI-Public10610586027741
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K021999
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 09/07/2021
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 Health Professional
Device Model Number21-2966-24
Device Catalogue Number21-2966-24
Device Lot Number4057906
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 03/15/2021
Supplement Date Received by Manufacturer08/08/2021
Initial Report FDA Received Date04/12/2021
Supplement Report FDA Received Date09/07/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device N
Patient Sequence Number1
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