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

Model Number 8884721252

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Insufficient Information (4580)

Event Date 02/27/2021

Event Type  malfunction  

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 Description

The customer reported that after inserting the ng tube and confirming the placement with xray, the rn was pulling the guidewire out and the green cap on the end popped off exposing the hooked sharp end of the guidewire causing the nurse to injure herself.The incident did not require any medical intervention.

Event Description

The customer reported that after inserting the ng tube and confirming the placement with xray, the rn was pulling the guidewire out and the green cap on the end popped off exposing the hooked sharp end of the guidewire causing the nurse to injure herself.The incident did not require any medical intervention.Additional information received from the initial reporter stated that the injury was moderate; no stitches required but the nurse did bleed quite a bit and had some mild pain.The nurse has fully recovered.No delay to the procedure being performed however nurse did have to take time away from other patient care to tend to her injury.Also made hand washing and delicate procedures (drawing blood etc) more challenging with a wound at the tip of her finger.

Manufacturer Narrative

Additional event information was received from the initial reporter.Based on the updated information.

• Brand Name: ENTFLX 12FR;43IN W/STYL YPORT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11558283
• MDR Text Key: 241938220
• Report Number: 9612030-2021-02823
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884721252
• Device Catalogue Number: 8884721252
• Device Lot Number: 2033604864
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/03/2021
• Patient Sequence Number: 1