MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB ENFIT EDI CATHETER; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 6FR/50 CM

Device Problem Unintended Movement (3026)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 02/21/2024

Event Type  Injury  

Event Description

It was reported that a patient that was on ventilatory therapy with nava (neurally adjusted ventilatory assist) mode of ventilation.The patient begun experiencing bradycardia and desaturation.An x-ray examination was performed, and it was discovered that the edi catheter was malpositioned.The edi catheter was withdrawn, and a lateral x-ray examination was conducted which noted free air and a gastric perforation was confirmed.The patient underwent surgery, and the perforated bowl was repaired.The patient remained on conventional ventilation in stable condition.Manufacturer¿s ref #: (b)(4).

• Brand Name: ENFIT EDI CATHETER
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 18888117
• MDR Text Key: 337469447
• Report Number: 3013876692-2024-00016
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6FR/50 CM
• Device Catalogue Number: 6883899
• Device Lot Number: 3000353933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2024
• Distributor Facility Aware Date: 02/22/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2024
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening