MAUDE Adverse Event Report: COVIDIEN 10FR 43 IRIS FEEDING TUBE ENF; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 461043E

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/22/2019

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 the dobbhoff tube was removed with difficulty.In addition the customer reported that the covering of the dobbhoff weight was missing.The flexible microloaryngoscope was entered to the right nasal airway.The airway was inspected all the way to the nasopharynx.No foreign was encountered.Flexible microlaryngoscope was then entered through the left nasal airway.The left airway was inspected and found free of any foreign body.Ct scan was done and there appears to be right-sided nose ring.No additional foreign body is seen.

• Brand Name: 10FR 43 IRIS FEEDING TUBE ENF
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire st; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9513749
• MDR Text Key: 172705317
• Report Number: 1282497-2019-08840
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 20884521706122
• UDI-Public: 20884521706122
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461043E
• Device Catalogue Number: 461043E
• Device Lot Number: 1043093018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1