MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NASOGASTRIC STABILIZATION DEVICES,STATLOCK®,ATTACHED SKIN PREP

Model 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	07/16/2021
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.
Event or Problem Description
It was reported that the statlock did not stay in place and often resulted in unintentional removal of nasogastric tubes.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "incorrect design of diameter at the end of the lumen or inadequate material selection during design phase".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿non-sterile.Ready to use.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.Safety and efficacy considerations: single use only.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: h.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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the statlock did not stay in place and often resulted in unintentional removal of nasogastric tubes.

• Brand Name: NASOGASTRIC STABILIZATION DEVICES,STATLOCK®,ATTACHED SKIN PREP
• Common Device Name: STATLOCK
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12294457
• Report Number: 1018233-2021-04822
• Device Sequence Number: 4847816
• Product Code: KMK
• UDI-Device Identifier: 10801741076173
• UDI-Public: (01)10801741076173
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2021

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 Model Number: NG0120
• Device Catalogue Number: NG0120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 08/09/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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