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

Model Number 8884711253

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

The customer reported they had a problem inserting the enteral tube due to kinking of the material.An attempt was made to pass it with x-ray, but it was not successful due to the probe showing memory.

Manufacturer Narrative

A device history record of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.The sample was not provided for evaluation however a photograph was provided for evaluation; the reported condition stated by the customer could not be confirmed solely by the photo.The physical sample is necessary in order to examine and confirm quality specifications.The root cause and corrective actions could not be identified.This complaint will be closed with no further action.If a sample is received, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.

• 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
• MDR Report Key: 11285893
• MDR Text Key: 230479059
• Report Number: 9612030-2021-02794
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518803
• UDI-Public: 10884521518803
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

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
• Device Operator: No Information
• Device Model Number: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: 1933013464
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 04/05/2021
• Patient Sequence Number: 1