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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 12FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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COVIDIEN 12FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Model Number 461243E
Medical Device Problem Codes Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/07/2020
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 the kangaroo iris feeding tube enfit port broke at the soft rubber y port hub below the threads.Entire threaded port was removed.This caused leaking of enteral nutrition and tube replacement.No patient injury was reported.
 
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Brand Name
12FR 43 IRIS FEEDING TUBE ENF
Common Device Name
GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key10998579
Report Number1282497-2020-09778
Device Sequence Number3822938
Product Code PIF
UDI-Device Identifier20884521742229
UDI-Public20884521742229
Combination Product (Y/N)N
Initial Reporter StateWI
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) 12/11/2020
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 Number461243E
Device Catalogue Number461243E
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/08/2020
Initial Report FDA Received Date12/13/2020
Patient Sequence Number1
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