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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN JOEY SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL
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COVIDIEN JOEY SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 765559
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 03/02/2020
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 there was a complete detachment of the clear tubing from the safety spike.The staff tried to repair the leak with waterproof tape to no avail.There was no patient injury.
 
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Brand Name
JOEY SAFETY SCREW SPIKE SET
Common Device Name
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key9956923
Report Number1282497-2020-09007
Device Sequence Number2818258
Product Code LZH
UDI-Device Identifier10884521155824
UDI-Public10884521155824
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) 04/14/2020
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 Number765559
Device Catalogue Number765559
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/08/2020
Initial Report FDA Received Date04/14/2020
Patient Sequence Number1
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