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

Catalog Number	NG0120
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
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 nasogastric statlocks were not sticking to the patients even after using the preparation pad.
Additional Manufacturer Narrative
The reported event is inconclusive as representative lot samples evaluated are within specification but condition of the used original sample is unknown.No actions can be taken at this time since a root cause was not identified.Visual: received three (3) unopened statlock nasogastric stabilization device.Adhesiveness was tested by placing all three (3) nasogastric stabilization device onto plastic sample bag.Samples adhered onto surface.Therefore, product meets specification.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: 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.Contraindications: known tape or adhesive allergies.Warnings and precautions: avoid contacting the statlock device with alcohol or acetone, both can weaken bonding of components and the statlock device pad adherence.Correction: d, h.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 nasogastric statlocks were not sticking to the patients even after using the preparation pad.

• Brand Name: CATHETER STABILIZATION DEVICE
• Common Device Name: 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 30014 ; 7707846100
• MDR Report Key: 20586986
• Report Number: 1018233-2024-06920
• Device Sequence Number: 8797377
• Product Code: KMK
• UDI-Device Identifier: 10801741076173
• UDI-Public: (01)10801741076173(11)240323(17)270128(10)JUJP8503
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• 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): 02/18/2025

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: JUJP8503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2024
• 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