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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SECURE; 3000 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET
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SECURE; 3000 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET Back to Search Results
Model Number 66631
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 06/25/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The reported condition was verified.A batch review was conducted and there were no deviations related to this reported condition during the quality control inspection of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that a small black floating particle was found inside a secure eva dual chamber bag.It was further reported that a 0.2 micron filter was used to pump the order and that the filter integrity test passed.The floating particle was noted by the pharmacy during the packaging process.There was no patient involvement.No additional information is available.
 
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Brand Name
SECURE
Common Device Name
3000 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET
MDR Report Key12277563
Report Number1937141-2021-00016
Device Sequence Number14159650
Product Code KPE
UDI-Device Identifier20812496011514
UDI-Public20812496011514
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K960581
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) 08/04/2021
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 Number66631
Device Catalogue Number66631
Device Lot Number66631-A6959
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 Date08/04/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured10/30/2020
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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