MAUDE Adverse Event Report: VYGON POLYURETHANE NUTRISAFE 2 FEEDING TUBES; POLYURETHANE NUTRISAFE 2 FEEDING TUBES,

Model Number 1364.042

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem Internal Organ Perforation (1987)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

The sample has been kept and will be sent for investigation.The (b)(6) competent authority is aware of event.We have checked our history of complaints on this code these 2 last years (2016,2017, 2018).We received last year another complaint with a stomach wall perforation.This happened during a laparoscopy.The examination of the involved sample didn't shown any non conformity.The device was not the cause of that wall perforation.There is no complaint on this batch.

Event Description

Neonate had a feeding tube in the stomach.The patient developed an acute abdomen.During the following surgery they found that the abdominal wall have rupture.The tube were placed under sterile conditions.No extended dwell time.Feeding of nutrition gradually breast milk.Patient currently stable.Neonate had a feeding tube in the stomach.The patient developed an acute abdomen.During the following surgery they found that the abdominal wall have rupture.The tube were placed under sterile conditions.No extended dwell time.Feeding of nutrition gradually breast milk.Patient currently stable.

• Brand Name: POLYURETHANE NUTRISAFE 2 FEEDING TUBES
• Type of Device: POLYURETHANE NUTRISAFE 2 FEEDING TUBES,
• Manufacturer (Section D): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• Manufacturer (Section G): VYGON; 5 rue adeline; ecouen, 95440 ; FR 95440
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 7717597
• MDR Text Key: 114935115
• Report Number: 2245270-2018-00051
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K060944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1364.042
• Device Lot Number: 120418FF
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention