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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 924 SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL
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COVIDIEN 924 SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 775759
Medical Device Problem Codes Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/02/2019
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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event or Problem Description
The customer reported the threaded punch connection is leaking and detaching when the nutrition is flowing making the nutrition leak.This is occurring at the connection of the set to the feeding bottle.
 
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Brand Name
924 SAFETY SCREW SPIKE SET
Common Device Name
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key9134608
Report Number1282497-2019-08675
Device Sequence Number2616977
Product Code LZH
UDI-Device Identifier20884521155739
UDI-Public20884521155739
Combination Product (Y/N)N
Initial Reporter CountryCO
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) 09/30/2019
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 Number775759
Device Catalogue Number775759
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/20/2019
Initial Report FDA Received Date09/30/2019
Patient Sequence Number1
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