MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 10FR;43IN W/STYLET EN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711006E
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 distal end (spiral) of the guide wire stretches when attempting to remove it.There was no patient injury.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the issue described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One digital photo and one physical sample without original package or lot number was received for evaluation; the guide wire¿s tip was stretched.The issue reported by the customer is confirmed.The most likely root cause for the reported issue could be due to incorrect technique if the instructions for use (ifu) are not followed.Per the ifu the proper procedure for insertion of the feeding tube and extraction of the stylet is using a syringe to inject approximately 10 cc of water into the tube to activate the hydromer coating.Based on the available information and investigation, no action plan is deemed required at this time.We will keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: DOBBHOFF 10FR;43IN W/STYLET EN
• 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: 10206478
• Report Number: 9612030-2020-02512
• Device Sequence Number: 19486237
• Product Code: KNT
• UDI-Device Identifier: 10884521582903
• UDI-Public: 10884521582903
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 8884711006E
• Device Catalogue Number: 8884711006E
• Device Lot Number: 1809389864
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 09/21/2020
• Patient Sequence Number: 1