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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 Difficult to Remove (1528)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 08/27/2021
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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  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 guide does not come out, therefore the device is considered in poor condition.
 
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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 Key12521408
Report Number9612030-2021-03043
Device Sequence Number17201305
Product Code KNT
UDI-Device Identifier10884521518872
UDI-Public10884521518872
Combination Product (Y/N)N
Initial Reporter CountryCO
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) 09/23/2021
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 Number8884721088
Device Catalogue Number8884721088
Device Lot Number1834002364
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/08/2021
Initial Report FDA Received Date09/23/2021
Patient Sequence Number1
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