MAUDE Adverse Event Report: 3M HEALTH CARE 3M NASOGASTRIC SECUREMENT DEVICE, LARGE; TAPE AND BANDAGE, ADHESIVE

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Aspiration/Inhalation (1725)

Event Date 06/08/2023

Event Type  Injury  

Manufacturer Narrative

Not provided.A sample was not available for return for analysis and information regarding how the securement device was applied and whether the nasogastric tube was clean and dry before application of the adhesive was not reported.For this case, an 8 french tube was used with the large device, 1501ng.The instructions for use state that for a small device, 1500ng, is designed to fit nasogastric tubes 8 -12 french.The large device, 1501ng, is designed to fit nasogastric tubes 10-18 french.3m will continue to monitor.

Event Description

Received from great britain: a customer alleged that adhesion of a 3m nasogastric securement device, large, 1501ng, was not adequate to secure a nasogastric tube, and as a result the nasogastric tube slipped, leading to aspiration of the feed.Invasive intervention was reported; the type of intervention performed was not reported.

Manufacturer Narrative

A1-a6: information not provided.B5: additional information added.G3: date received by manufacturer updated.H6: added code 4638, endoscopic procedure.H10: a sample was not available for return for analysis and information regarding how the securement device was applied and whether the nasogastric tube was clean and dry before application of the adhesive was not reported.A lot number was provided; review of batch records for this lot did not indicate any defect with the product.For this case, a use error occurred where an 8 french tube was used with a large 3m nasogastric securement device, 1501ng.The instructions for use state that for a small device, 1500ng, is designed to fit nasogastric tubes 8 -12 french, and the large device, 1501ng, is designed to fit nasogastric tubes 10-18 french.3m will continue to monitor.

Event Description

Received from great britain: a customer alleged that adhesion of a 3m nasogastric securement device, large, 1501ng, was not adequate to secure a nasogastric tube, and as a result a patient's nasogastric tube slipped, leading to aspiration of the feed.Intubation, ventilation, and bronchoscopy were performed.The tube had been changed that day from a 14fr to a size 8fr fine bore tube; however, a 3m nasogastric securement device, large, 1501ng was used.The length of time from insertion of the tube to the incident was hours.The patient was fine and was discharged from critical care.

• Brand Name: 3M NASOGASTRIC SECUREMENT DEVICE, LARGE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M BROOKINGS; 601 22nd ave south; po box 5227; brookings, sd 57006 ; GM 57006
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144-1000 ; 6514612670
• MDR Report Key: 17240098
• MDR Text Key: 318239752
• Report Number: 2110898-2023-00053
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 1501NG
• Device Lot Number: 2201AM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2022
• 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