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

Model Number	721088CN
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
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.
Event or Problem Description
The customer reported that the feeding tube was inserted and the guidewire would not come out.The nurse called the nurse manager over and they removed the tube but the guidewire remained stuck in the tube.
Additional Manufacturer Narrative
Regarding the use of "4247: appropriate term/code not available - the device has been altered.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One decontaminated sample was received at the manufacturing site for evaluation.Upon a visual evaluation of the sample, an external material to cardinal health¿s finished good was observed to be placed and stuck inside of the tubing.The tubing was cut into two pieces to inspect for any occlusions and remove the guidewire.The "guidewire" (not manufactured by cardinal health) was found to be damaged and too large to be inserted into the bottom of the feeding tube.Because the feeding tube had to be cut to remove the placed guidewire, a guidewire manufactured by cardinal health could not be placed in the tubing to confirm that it could be removed as intended.The reported issue could not be confirmed as related to cardinal health¿s manufacturing/product process as the product has been altered.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 10FR;43IN W/ STYLETCN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10264599
• Report Number: 1282497-2020-09192
• Device Sequence Number: 16798668
• Product Code: KNT
• UDI-Device Identifier: 20884521033617
• UDI-Public: 20884521033617
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

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: 721088CN
• Device Catalogue Number: 721088CN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 12/10/2020
• Patient Sequence Number: 1