MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 10FR;43IN W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711006
Medical Device Problem Codes	Material Puncture/Hole (1504); Difficult to Remove (1528)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/27/2021
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
As reported through an anvisa notification after the passage of the sne, when removing the guide wire, the plastic tip loosens, leaving the pointed part exposed and making it difficult to withdraw the guide.
Additional Manufacturer Narrative
Section e1 initial reporter phone number field was entered incorrectly in the report number 9612030-2021-02902.The initial reporter did not provide a phone number.

• 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 Key: 11827117
• Report Number: 9612030-2021-02902
• Device Sequence Number: 11841942
• Product Code: KNT
• UDI-Device Identifier: 10884521518780
• UDI-Public: 10884521518780
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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 Number: 8884711006
• Device Catalogue Number: 8884711006
• Device Lot Number: 1929500964
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/09/2021
• Patient Sequence Number: 1