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

Model Number ENFIT 6FR/49 CM

Device Problem Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2023

Event Type  malfunction  

Event Description

It was reported that after removal of the edi catheter, the user measured the length and found that the total length was 52 cm instead of specified 49 cm.There was no patient harm.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: 18137897
• MDR Text Key: 328129538
• Report Number: 8010042-2023-02218
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENFIT 6FR/49 CM
• Device Catalogue Number: 6883898
• Device Lot Number: 3000314480
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1