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

Model Number	711253CN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the blue tip stylet snapped off of the 12 fr dobbhoff feeding tube.No patient injury was reported.
Additional Manufacturer Narrative
The device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.One sample was received for evaluation.Visual and functional inspection was performed and found the blue tip stylet snapped off the 12 fr dobbhoff feeding tube.A root cause could not be found or determined relating to the manufacturing or production process.No corrective action is being taken since the failure could not be confirmed related to manufacturing/production process.However, further analysis was requested from the supplier.Per the supplier, the hub assembly with stylet undergoes two tests during manufacturing.A functional test and a visual test.In the functional part of the test, 2lbs of tension is applied.The tube assembly, stylet bell and stylet tip are all tested.If the tensile strength does not meet specification, or if the force of the stiletto bell is less than specified or if the stylet tip separates from the stylet, the device fails.During the visual test, the stylet point is analyzed for the presence of burrs or sharp points and the stylet tip is checked for incorrect, incomplete, missing, damage or improper shapes and will fail if any of these are found.Due to this notification, the aql was raised from reduced to rigorous.This complaint will be used for tracking and trending purposes.

• Brand Name: DOBBHOFF 12FR;43IN W/ STYLECN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12356977
• Report Number: 1282497-2021-10567
• Device Sequence Number: 3726392
• Product Code: KNT
• UDI-Device Identifier: 10884521146136
• UDI-Public: 10884521146136
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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 Model Number: 711253CN
• Device Catalogue Number: 711253CN
• Device Lot Number: 201040407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown