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

Model Number 8FR/50 CM

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2020

Event Type  malfunction  

Event Description

It was reported that while the patient was connected to a ventilator during nava (neurally adjusted ventilatory assist) mode of ventilation, administration of medication was performed via the edi catheter (a single-use nasogastric feeding tube with measuring electrodes positioned in the esophagus, measuring the electrical activity of the diaphragm).The medication came out of the patient's nose.When the edi catheter was pulled out, a hole was noted in the edi catheter in the area that was in the patient¿s nasal cavity.There was no patient injury.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

The edi catheter was not returned but pictures were provided showing a hole in the insulation in the invasive part at the 22 cm marking.The edi catheter was fixed at 24 cm, so the hole was in the patient¿s nasal cavity.Leakage tests are performed during manufacturing before the punching of the feeding holes and final inspection is visual.A hole of this size would have been detected during the leakage test.The root cause of the hole in the edi catheter insulation has not been able to be determined.

Event Description

Manufacturer's ref # (b)(4).

• Brand Name: EDI CATHETER ENFIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 9641957
• MDR Text Key: 189843677
• Report Number: 8010042-2020-00052
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• PMA/PMN Number: K153688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8FR/50 CM
• Device Catalogue Number: 6883900
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1