MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 CATHETER STABILIZATION DEVICE; NASOGASTRIC STATLOCK

Catalog Number	NG0120
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the customer stated that repeatedly, the adhesive lifts from the nose and peels back after 4 hours, the tape sticks to itself when you wrap it around the nasogastric but then the tube slides through it.This was a huge risk as it allows the tube to slide out, increasing the risk of aspiration of the tube feed and also the loss of a tube as it can slip out and require a new one to be reinserted this issue was reported by 6 different nurses over the past few days.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The reported event is addressed within the labeling as it states" "warnings and precautions: avoid contacting the statlock device with alcohol or acetone, both can weaken bonding of components and the statlock device pad adherence.Remove oil and moisturizer from targeted skin area.Apply skin prep to the targeted statlock device area for skin protection and enhanced pad adherence.Allow to dry completely".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Corrections: d, f, h udi format updated with available product information per gudid.H11: sections a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the customer stated that repeatedly, the adhesive lifts from the nose and peels back after 4 hours, the tape sticks to itself when you wrap it around the nasogastric but then the tube slides through it.This was a huge risk as it allows the tube to slide out, increasing the risk of aspiration of the tube feed and also the loss of a tube as it can slip out and require a new one to be reinserted.This issue was reported by 6 different nurses over the past few days.

• Brand Name: CATHETER STABILIZATION DEVICE
• Common Device Name: NASOGASTRIC STATLOCK
• 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: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23278019
• Report Number: 1018233-2025-09064
• Device Sequence Number: 5559600
• Product Code: KMK
• UDI-Device Identifier: 10801741076173
• UDI-Public: (01)10801741076173(11)250530(17)280428(10)JUKS8501
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: NG0120
• Device Lot Number: JUKS8501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown