MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB EDI CATHETER ENFIT 8FR/100 CM, 5PCS; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	6883901
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a leakage in the invasive part of the edi catheter and nutrition came out of the patient's nose.There was no patient harm.Manufacturer¿s ref #: (b)(4).
Additional Manufacturer Narrative
No lot # received, therefore manufacture date is unknown.
Additional Manufacturer Narrative
The reported issue involves an edi catheter used during nava (neurally adjusted ventilatory assist) ventilation, a mode that provides respiratory support based on the electrical activity of the diaphragm (edi).Nava synchronizes assistance with the patient's breathing efforts and requires an active respiratory drive.The edi catheter, a single-use nasogastric (ng) feeding tube, is equipped with measuring electrodes positioned in the esophagus to monitor diaphragm activity across all modes, including standby.It was reported that the invasive part of the edi catheter developed a leakage, causing nutrition to leak from the patient¿s nose.The edi catheter was replaced, and no further complications occurred.Upon receiving the edi catheter for investigation, a visual inspection revealed no external anomalies, and its full length was intact.However, a leakage test using a syringe filled with water confirmed a leak at the ninth electrode.The lot number of the affected edi catheter was unknown, preventing a device history record review.During manufacturing, leakage tests are conducted before the feeding holes are punched, and a final visual inspection is performed.Any holes or damage should have been detected at that stage.Based on the available information, no material deficiency was identified.The edi catheter appears to have sustained damage, but the cause remains unknown.The exact root cause of the hole in the edi catheter¿s insulation could not be determined.
Event or Problem Description
Manufacturer's ref #: (b)(4).

• Brand Name: EDI CATHETER ENFIT 8FR/100 CM, 5PCS
• Common Device Name: 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: 20439155
• Report Number: 8010042-2024-0001666
• Device Sequence Number: 12761185
• Product Code: PIF
• UDI-Device Identifier: 17325710004644
• UDI-Public: (01)17325710004644
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K153688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2024

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: Health Professional
• Device Model Number: 6883901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown