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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 10FR;43IN W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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COVIDIEN DOBBHOFF 10FR;43IN W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number 8884711006
Medical Device Problem Codes Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/14/2019
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 that the metal wire from the stylet does not come out of the tube, it broke the external part that is at the widest exit of the feeding tube.There was no patient harm reported.
 
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Brand Name
DOBBHOFF 10FR;43IN W/STYLET
Common Device Name
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
MDR Report Key9637203
Report Number9612030-2020-02398
Device Sequence Number401382
Product Code KNT
UDI-Device Identifier10884521518780
UDI-Public10884521518780
Combination Product (Y/N)N
Initial Reporter CountryBR
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) 01/28/2020
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 Number8884711006
Device Catalogue Number8884711006
Device Lot Number1825513864
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/14/2020
Initial Report FDA Received Date01/28/2020
Patient Sequence Number1
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