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

Model Number 8884711253

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  malfunction  

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 Description

The customer reported after a few days of use they found a kink at the 15 mark of the catheter preventing infusion of food.There was no harm to the patient.

Manufacturer Narrative

The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One digital picture was provided for the evaluation.From the picture provided, it was not possible to confirm the reported issue.No physical sample has been received for the evaluation.Without a physical sample being returned, the root cause for the reported condition cannot be specifically identified.No corrective actions are deemed necessary at this time.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa 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: 10325858
• MDR Text Key: 200406038
• Report Number: 9612030-2020-02549
• 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: 09/21/2020

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 Number: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: 2001402264
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 07/22/2020
• Supplement Dates FDA Received: 09/21/2020
• Patient Sequence Number: 1