MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UKNOWN NASOGASTRIC TUBE

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive as no sample was returned for evaluation.A potential root cause could be due to "inadequate material selection during design phase." the device was not returned for evaluation.The lot number was unknown therefore the device history record could not be reviewed.The product catalog number for this device was unknown therefore the labelling review was not performed.

Event Description

It was reported that the 14 fr pediatric orogastric tube (nasogastric tube) was leaked from the anti-reflux blue tubing junction.The leak was discovered after the nasogastric feeding tube was placed in the patient.The rn got a new tube and tested it and no leaks were found.The patient was informed of the issue.The tube was removed and replaced by the new one.It was inserted and auscultated in the abdomen and performed as expected.The placement of the new tube was confirmed by kidney, ureter, and bladder (kub) x-ray.Patient care was resumed as planned.

• Brand Name: UKNOWN NASOGASTRIC TUBE
• Type of Device: NASOGASTRIC TUBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 10167256
• MDR Text Key: 195550009
• Report Number: 1018233-2020-03936
• Device Sequence Number: 1
• Product Code: BSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/27/2020
• 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
• Patient Age: 43 YR