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

Model Number 8884711253

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Foreign Body In Patient (2687)

Event Date 11/24/2020

Event Type  Injury  

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 that at approximately 5:30pm the patient underwent an eda (upper digestive endoscopy) for investigation of a gastric ulcer due to the patient complaining of abdominal pain for 24 hours.When performing the procedure, a damaged sne (nasoenteral probe) was observed and removed by the endoscopist and a new enteral tube was passed through the eda.The first enteral tube presented was missing the radiopaque metallic tip.Additional information provided stated that there was an introduction of the colonoscope to the cecum, with the presence of a moderate amount of pasty, liquid and solid brown residues throughout the entire colon.Presence of a foreign body (end of the enteral tube) between the cecum and ascending colon.The foreign body was removed with the aid of a polypectomy loop, without complications and without lacerations in the path.

Manufacturer Narrative

Additional information: h4 device manufacture date added.The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A physical sample was not returned for evaluation however a picture was provided.The sample analysis was done using the pictures.A bad assembly was observed in the bolus of the tube that caused the detachment of the piece.After evaluation of the photo, the reported condition was confirmed.The product does not meet specification.During the investigation with the multidisciplinary team, a walk through was performed of the manufacturing process.After reviewing and replicating the reported condition, it was concluded that the potential root cause is the lack of solvent in the component.A quality alert was made to notify personnel of the reported condition.A training was performed in all shifts, where it is mentioned how long to dip the bolus and tube into the solvent and how to assemble both components together.Also, a production notification was performed to all personnel to ensure that they are aware of the condition reported by the customer.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: 10998527
• MDR Text Key: 221231274
• Report Number: 9612030-2020-02715
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: 2002101564
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other