MAUDE Adverse Event Report: COVIDIEN PED-TBE 6FR;20IN WGT W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884730741

Device Problems Separation Failure (2547); Material Twisted/Bent (2981)

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

Event Date 12/08/2020

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 that the patient had an intolerance to the oral route at the time so the doctor on duty decided to pass an advanced gastric tube.Following aseptic technique and biosafety standards, the probe was placed.Initially the guidewire was washed so that it could be removed more easily and was entered and removed so that there was no adherence.After this, they proceeded to take measurements from the labial corner to the earlobe and from there to the xiphoid process, and a mark was made.Measuring 10cm from there another mark was made.They proceeded the passage to the first mark.The patient was then placed in decubitis right side and then advanced the passage to the second mark.They took an rx and the tube was well positioned so they tried to remove the guide but it would not come out.The doctor on duty assessed and proceeded to withdraw the guide.When removing the guidewire, there was evidence that it was entangled in the probe which made it impossible to pass it.Therefore, the same process was carried out with another probe.Rx was taken and when the tube was well positioned the guide was removed.There was no injury to the patient.

• Brand Name: PED-TBE 6FR;20IN WGT 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 Key: 11003839
• MDR Text Key: 226015143
• Report Number: 9612030-2020-02716
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 30884521009619
• UDI-Public: 30884521009619
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884730741
• Device Catalogue Number: 8884730741
• Device Lot Number: 1821825464
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1