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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 Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/06/2021
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 an unspecified numbers of non-dehp standard bore catheter extension sets were not working.The event was further described as; when priming an intravenous (iv) fluid, the iv fluid would leak around.There was no patient involvement.No additional information is available.
 
Additional Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were 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 Key12425836
Report Number1416980-2021-05457
Device Sequence Number19647052
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,consum
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/07/2021
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 Other
Device Catalogue Number2N1333
Device Lot NumberUR20H17029
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/11/2021
Supplement Date Received by Manufacturer10/01/2021
Initial Report FDA Received Date09/03/2021
Supplement Report FDA Received Date10/07/2021
Date Device Manufactured08/18/2020
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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