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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO-VOLUME RADIATION STERILIZED EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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MICRO-VOLUME RADIATION STERILIZED EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2N3348
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/14/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that a micro-volume extension set had visible black material in the luer lock identified before use.There was no patient involvement.No additional information is available.
 
Additional Manufacturer Narrative
H10: the device was received for evaluation.Visual inspection was performed which observed particulate matter in the microbore winged female luer lock adapter.A higher magnification was performed on the particulate matter and it was characterized as fine reflective metallic powder.The reported condition was verified.The cause of the particulate matter was due to the machine during manufacturing process.A nonconformance has been opened to address this issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
MICRO-VOLUME RADIATION STERILIZED EXTENSION SETS
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12100726
Report Number1416980-2021-04042
Device Sequence Number19876244
Product Code FPA
UDI-Device Identifier00085412004822
UDI-Public(01)00085412004822
Combination Product (Y/N)Y
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K811078
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date (Section B) 08/11/2021
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 Catalogue Number2N3348
Device Lot NumberUR20I21029
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2021
Initial Date Received by Manufacturer 06/14/2021
Supplement Date Received by Manufacturer08/04/2021
Initial Report FDA Received Date07/01/2021
Supplement Report FDA Received Date08/11/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured09/24/2020
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
Concomitant Medical Products
and Therapy/Usage Dates
NA.
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