MAUDE Adverse Event Report: MOOG / ZEVEX, INC. MOOG ENTERAL PUMP DELIVERY SET; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number INF-0500-A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Strangulation (2084)

Event Date 03/24/2021

Event Type  Death  

Event Description

Enteral feeding tubing was delivered directly to patient's mother by (b)(4).The child's mother connected the enteral feeding tubing to child's gastrostomy (feeding) tube.The child reportedly strangled on the tubing while not in the mother's presence.Reportedly, the mother initiated cpr and child was transported to a hospital then pronounced brain dead on (b)(6) 2021.Fda safety report id# (b)(4).

• Brand Name: MOOG ENTERAL PUMP DELIVERY SET
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): MOOG / ZEVEX, INC.; salt lake city UT 84123
• MDR Report Key: 11641070
• MDR Text Key: 244637437
• Report Number: MW5100677
• Device Sequence Number: 1
• Product Code: PIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: INF-0500-A
• Was Device Available for Evaluation?: No
• 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): Death
• Patient Age: 15 MO
• Patient Weight: 9