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	Needle Stick/Puncture (2462)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).While the health care professional did experience a stick/puncture it was from the guide wire of the feeding tube and not a needle.The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the nurse was removing the stylet from a dobbhoff feeding tube and the cap broke off exposing the wire and cut her finger.

• Brand Name: DOBBHOFF 12FR;43IN W/ STYLECN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10093703
• Report Number: 1282497-2020-09086
• Device Sequence Number: 14304532
• Product Code: KNT
• UDI-Device Identifier: 10884521146136
• UDI-Public: 10884521146136
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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
• Operator of Device: No Information
• Device Model Number: 711253CN
• Device Catalogue Number: 711253CN
• Device Lot Number: 2222200290018
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 05/27/2020
• Patient Sequence Number: 1