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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 10FR;43IN W/STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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CARDINAL HEALTH ENTRFLX 10FR;43IN W/STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number 8884721088
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 08/11/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
 
Event or Problem Description
The customer reported a decapitated weighted dobhoff feeding tube tip is seen within the proximal stomach.
 
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Brand Name
ENTRFLX 10FR;43IN W/STY YPORT
Common Device Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
CARDINAL HEALTH
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
MDR Report Key12561718
Report Number9612030-2021-03047
Device Sequence Number13793303
Product Code KNT
UDI-Device Identifier10884521518872
UDI-Public10884521518872
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Risk Manager
Type of Report Initial
Report Date (Section B) 10/01/2021
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 Expiration Date04/30/2026
Device Model Number8884721088
Device Catalogue Number8884721088
Device Lot Number2114502764
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/23/2021
Initial Report FDA Received Date10/01/2021
Patient Sequence Number1
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