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

Model Number NG0120

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the statlock did not stay in place and often resulted in unintentional removal of nasogastric tubes.

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 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
• Type of Device: 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
• MDR Text Key: 265604577
• Report Number: 1018233-2021-04822
• Device Sequence Number: 1
• Product Code: KMK
• UDI-Device Identifier: 10801741076173
• UDI-Public: (01)10801741076173
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: NG0120
• Device Catalogue Number: NG0120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 12/28/2021
• 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 Outcome(s): Other