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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN K 924 1000ML BAG SET (IND PK); PUMP, INFUSION
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COVIDIEN K 924 1000ML BAG SET (IND PK); PUMP, INFUSION Back to Search Results
Model Number 773621
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/20/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event or Problem Description
The customer reported upon opening and first use, the devices started leaking from the bottom of the feed set that connects to the tubing.There was no patient harm.
 
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Brand Name
K 924 1000ML BAG SET (IND PK)
Common Device Name
PUMP, INFUSION
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key10351024
Report Number1282497-2020-09251
Device Sequence Number14207667
Product Code FRN
UDI-Device Identifier10884521000834
UDI-Public10884521000834
Combination Product (Y/N)N
Initial Reporter CountryCA
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/31/2020
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 No Information
Device Model Number773621
Device Catalogue Number773621
Device Lot Number183340149
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/23/2020
Initial Report FDA Received Date07/31/2020
Patient Sequence Number1
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