MAUDE Adverse Event Report: MAQUET MEDICAL SYSTEMS, USA MAQUET EDI CATHETER REF 6685775, 6/49 FR/CM; GASTROINTESTINAL, TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number MAQUET EDI CATHETER REF 6685775

Device Problem Material Discolored (1170)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2019

Event Type  malfunction  

Event Description

Upon extubation, maquet edi catheter ref 6685775, 6/49 fr/cm had a "burnt" - like appearance on end.Fda safety report id# (b)(4).

• Brand Name: MAQUET EDI CATHETER REF 6685775, 6/49 FR/CM
• Type of Device: GASTROINTESTINAL, TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): MAQUET MEDICAL SYSTEMS, USA
• MDR Report Key: 8735018
• MDR Text Key: 149356867
• Report Number: MW5087601
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAQUET EDI CATHETER REF 6685775
• Device Catalogue Number: MAQUET EDI CATHETER REF 668577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 7 DA
• Patient Weight: 1