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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2N1333
Medical Device Problem Code No Flow (2991)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/09/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that a non-dehp standard bore catheter extension set would not flow.It was further described as fluids would not allow to come down the iv tubing.This issues was identified during priming.There was no patient involvement.No additional information is available.
 
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
EXTENSION SETS
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12456564
Report Number1416980-2021-05605
Device Sequence Number1180628
Product Code FPA
UDI-Device Identifier00085412475394
UDI-Public(01)00085412475394
Combination Product (Y/N)Y
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K132734
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/12/2021
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 Other
Device Catalogue Number2N1333
Device Lot NumberUR21D21029
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/16/2021
Supplement Date Received by Manufacturer10/07/2021
Initial Report FDA Received Date09/10/2021
Supplement Report FDA Received Date10/12/2021
Date Device Manufactured04/22/2021
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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