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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 Obstruction of Flow (2423)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/05/2021
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 ten (10) non-dehp standard bore catheter extension sets were ¿block/clogged¿.It was further reported that it was impossible to empty the set unless by injecting liquid with an unspecified syringe by applying strong pressure on the plunger.There was no patient injury or medical intervention associated with this event.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 discarded; 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 Key12360254
Report Number1416980-2021-05191
Device Sequence Number19767054
Product Code FPA
UDI-Device Identifier00085412475394
UDI-Public(01)00085412475394
Combination Product (Y/N)Y
Initial Reporter CountryCA
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,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/28/2021
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 NumberUR21B25065
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/30/2021
Supplement Date Received by Manufacturer09/23/2021
Initial Report FDA Received Date08/24/2021
Supplement Report FDA Received Date09/28/2021
Date Device Manufactured02/26/2021
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
Concomitant Medical Products
and Therapy/Usage Dates
UNSPECIFIED SYRINGE; UNSPECIFIED SYRINGE
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