MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 8FR;43IN W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884710867
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The customer reported that when removing a stylet from an inserted dobbhoff, the blue cap on the stylet that covers the stylet became detached and the right index finger was punctured approximately ¼¿ length of the hooked part of the stylet.The tube was previously flushed to aid in stylet removal.The punctured area was washed immediately with soap and water.
Additional Manufacturer Narrative
A review of the device history record revealed no discrepancies that may have contributed to the reported condition.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and definitive root cause analysis.The reported issue could not be confirmed for this report as no physical samples were received for evaluation, however based on the description of the incident the most likely root cause indicates that this issue could occur during use if there are any deviations to the instructions of use (ifu).The ifu states that a once the tube position has been confirmed, reactivate the hydromer coating with another 10 cc of water before attempting removal if the stylet has been indwelling for any appreciable time.The issue can also occur if the piston on the machine is not set up correctly.The definite root cause for the reported condition cannot be specifically identified; therefore, corrective action will be limited to the manufacturing awareness this time.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: DOBBHOFF 8FR;43IN W/STYLET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9671556
• Report Number: 9612030-2020-02407
• Device Sequence Number: 14150938
• Product Code: KNT
• UDI-Device Identifier: 10884521518773
• UDI-Public: 10884521518773
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8884710867
• Device Catalogue Number: 8884710867
• Device Lot Number: 1909903364
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 06/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other