MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD NASOGASTRIC SUMP TUBE

Catalog Number 0046160

Device Problem Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that he tubing from the iv line was inadvertently connected to the nasogastric tube, the iv solution infused into the ng tube as normal saline.Facility reported no impact to the pt.However, the facility feels that the connections are similar and can be easily mistaken for an intravenous solution setup and infusion.

Manufacturer Narrative

The device was not returned for eval.The lot number is unk therefore a device history record could not be reviewed.The complaint is confirmed since the user failed to follow the instructions for use of the product.(b)(4).

• Brand Name: NASOGASTRIC SUMP TUBE
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA ELE CUIDADO DE LA SALUD; km 7. carretera internacional; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4657993
• MDR Text Key: 20152825
• Report Number: 1018233-2015-00105
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0046160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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