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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MICROBORE EXTENSION SET 60IN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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COVIDIEN MICROBORE EXTENSION SET 60IN; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number 60ES
Medical Device Problem Code Complete Blockage (1094)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 03/25/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation because it was discarded; 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 tubing has a blockage at the male adaptor side and will not let the formula/milk pass through into feeing tube.The customer also stated that the connection to the feeding tube has been difficult.No patient injury was reported.
 
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Brand Name
MICROBORE EXTENSION SET 60IN
Common Device Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
MDR Report Key11616455
Report Number9612030-2021-02841
Device Sequence Number3049181
Product Code KNT
UDI-Device Identifier20884521143910
UDI-Public20884521143910
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 04/05/2021
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 Number60ES
Device Catalogue Number60ES
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/31/2021
Initial Report FDA Received Date04/05/2021
Patient Sequence Number1
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