MAUDE Adverse Event Report: COVIDIEN MONOJECT 6 ML ENFIT SYRINGE; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	406SE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Death (1802)
Date of Event	09/16/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that a nasogastric tube ruptured resulting in a patient aspirating.The nasogastric tube involved in the incident was from another manufacturer (avanos - 10fr fine bore nasogastric corpak pur feeding tube).The syringe used to flush the blocked tube was a cardinal health 6ml enfit syringe.It was reported that there were several factors involved in this incident and the customer is unable to identify exactly what caused the rupture; the tube had been in place for 6 weeks, the patient had a gastroscopy procedure while the tube remained in place, and post procedure the tube became blocked so the nurse flushed the tube with coke using the cardinal health enfit 6ml syringe to unblock the tube.The feeding was recommenced and subsequently the patient aspirated.When this was identified, the feeding was ceased and the tube was removed, which was when the rupture was discovered.The patient was a critically unwell patient and passed away 12 days later.The customer reported that it is not believed that this incident caused the death but may have contributed to the patient¿s further deterioration.It was reported that the other manufacturer's (avanos) instruction for use (ifu) states that excessive syringe pressure should be avoided.

• Brand Name: MONOJECT 6 ML ENFIT SYRINGE
• Common Device Name: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 9396881
• Report Number: 1915484-2019-01102
• Device Sequence Number: 2903499
• Product Code: PNR
• UDI-Device Identifier: 10884521512849
• UDI-Public: 10884521512849
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2019

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?: No
• Operator of Device: No Information
• Device Model Number: 406SE
• Device Catalogue Number: 406SE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death