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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 12FR;43IN W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

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COVIDIEN DOBBHOFF 12FR;43IN W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES) Back to Search Results
Model Number 8884711253
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/12/2020
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been 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.  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 Description
The customer reported that the enteral probe was placed on (b)(6) 2020 and showed a leak, requiring replacement.The probe had a crack close to the number 90.
 
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Brand Name
DOBBHOFF 12FR;43IN W/STYLET
Type of Device
TUBES, GASTROINTESTINAL (AND ACCESSORIES)
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
Manufacturer (Section G)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX   22500
Manufacturer Contact
jill saraiva
15 hampshire street
mansfield, MA 02048
5086183640
MDR Report Key10298829
MDR Text Key199724372
Report Number9612030-2020-02535
Device Sequence Number1
Product Code KNT
UDI-Device Identifier10884521518803
UDI-Public10884521518803
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 07/20/2020
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
Device Operator No Information
Device Model Number8884711253
Device Catalogue Number8884711253
Device Lot Number2001402264
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/16/2020
Initial Date FDA Received07/20/2020
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
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