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

Model Number	6FR/49 CM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	12/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during patient treatment in invasive nava (neurally adjusted ventilatory assist) mode of ventilation, the patient developed a pneumothorax.The patient remained on the ventilator and was subsequently extubated with continued treatment in non invasive ventilation (niv) mode of ventilation.Final patient outcome was no injury.Manufacturer's ref #: (b)(4).
Additional Manufacturer Narrative
There was no demand for a ventilator investigation, and no logs are provided.The subjected edi catheter was scrapped.Evaluation of data from the user facility constitutes investigation.Ventilator settings were reportedly a nava level of 2.5, peep level at 6.5 cm h2o, upper pressure limit of 30 cm h2o and an o2 concentration of 28%.There were no issues with inserting and positioning of the edi catheter and no repositioning of the edi catheter was at any point performed during the usage time.According to the attending physician reviewing the case, neither the ventilator nor the chosen ventilation mode caused the event of pneumothorax.A check of the material parameters for the subjected edi catheter showed that all parameters were within the specified limits during manufacturing.The product met the final release criteria.There were no non-conformities identified with the batch.There is no evidence to support a technical malfunction of the edi catheter or the ventilator system.The underlying cause of the reported event has not been conclusively determined but was most likely patient related.There are no indications of ventilator malfunction.H3 other text : 4117.
Event or Problem Description
Manufacturer's ref #: (b)(4).

• Brand Name: ENFIT EDI CATHETER
• 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: 16768532
• Report Number: 3013876692-2023-00018
• Device Sequence Number: 6386467
• Product Code: PIF
• UDI-Device Identifier: 17325710004606
• UDI-Public: (01)17325710004606
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K153688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2023
• Report Date (Section F): 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6FR/49 CM
• Device Catalogue Number: 6883898
• Device Lot Number: 3000263414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 3 DA
• Patient Sex: Male
• Patient Weight: 9 KG
• Date Report Sent to FDA: 10/06/2023