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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECURE; 3000 ML EMPTY EVA SINGLE CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET
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SECURE; 3000 ML EMPTY EVA SINGLE CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET Back to Search Results
Model Number 66653
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 06/30/2021
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 floating black particle was found inside a secure eva 3000 ml bag.It was further reported that the fluid was filtered with a 0.2 micron filter and the filter integrity test passed.The floater was noted by the pharmacy during the packaging of the order.There was no patient involvement.No additional information is available.
 
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Brand Name
SECURE
Common Device Name
3000 ML EMPTY EVA SINGLE CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET
MDR Report Key12280350
Report Number1937141-2021-00017
Device Sequence Number2826274
Product Code KPE
UDI-Device Identifier20812496011835
UDI-Public20812496011835
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K030888
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source foreign,user facility
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/05/2021
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 Model Number66653
Device Catalogue Number66653
Device Lot Number66653-A6601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/06/2021
Initial Report FDA Received Date08/05/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured02/13/2020
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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