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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTAMIX; 3000 ML EMPTY EVA DUAL CHAMBER BAG
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EXACTAMIX; 3000 ML EMPTY EVA DUAL CHAMBER BAG Back to Search Results
Model Number H938905
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 08/10/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A photograph was provided indicating the reported tear as marked by the customer.The area indicated with the tear included a portion of the pharmacy label on the face of the large chamber of the bag.Should additional relevant information become available, a supplemental report will be filed.
 
Event or Problem Description
It was reported that a single unit of an exactamix dual chamber bag was found to be leaking via a tear.The leak was identified prior to use at a patient's home.There was no report of patient injury or medical intervention as a result of this event.No additional information is available.
 
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Brand Name
EXACTAMIX
Common Device Name
3000 ML EMPTY EVA DUAL CHAMBER BAG
MDR Report Key12485049
Report Number1937141-2021-00018
Device Sequence Number4221141
Product Code KPE
UDI-Device Identifier00085412477473
UDI-Public00085412477473
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
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 company representative,distri
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/16/2021
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 Lay User/Patient
Device Expiration Date11/27/2025
Device Model NumberH938905
Device Catalogue NumberH938905
Device Lot Number63630-A5971
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/19/2021
Initial Report FDA Received Date09/16/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured11/27/2020
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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