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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN JOEY 1000ML SAFETY SCREW SPIKE; PUMP, INFUSION, ENTERAL
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COVIDIEN JOEY 1000ML SAFETY SCREW SPIKE; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 765100
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/30/2020
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.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event or Problem Description
The customer reported that while attaching a new feeding set, the entire tube disconnected from the spike as soon as the bag was hung and formula was pouring out.The set was immediately removed and replaced.There was no patient harm.
 
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Brand Name
JOEY 1000ML SAFETY SCREW SPIKE
Common Device Name
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key10649164
Report Number1282497-2020-09526
Device Sequence Number17154808
Product Code LZH
UDI-Device Identifier20884521155784
UDI-Public20884521155784
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/08/2020
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 Number765100
Device Catalogue Number765100
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/07/2020
Initial Report FDA Received Date10/08/2020
Patient Sequence Number1
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