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

Model Number	NG0120
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Aspiration/Inhalation (1725)
Date of Event	11/18/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the clinician was using the nasogastric stabilization device to secure a dobhoff tube that had a smaller lumen for long term feedings.The manufacturer and catalog number of the dobhoff tube was unknown.It was reported that when the clinician found the patient expired, the stabilization device tape was still secured to the patient's nose, but the tube was no longer attached, and the patient had been aspirated.The facility requested to understand if the device was approved for use with smaller lumen feeding tubes or if an alternate device should be used.Per additional information received via email on 13 dec 2021, the facility contact nurse stated that the cause of death was aspiration.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The nasogastric statlock device is placed by wrapping around the ng tube, thus the device accommodates various sizes of ng tubes.There is additional labeling within the product which states to replace the nasogastric statlock device every 3-5 days.It is unknown when the nasogastric statlock device was applied, and it is unknown if the dobhoff tube referenced in the event was a nasogastric device as additional product information is not available.It is unknown if the reported event occurred right after placement or after use, therefore the reported event could be addressed in steps "user didn't properly place catheter" and "statlock not maintained on a daily basis", depending when the event occurred.The potential cause referenced is "user deviation from instructions for use", however there is no objective evidence to support or discard this cause.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: "ng statlock was designed to use to stabilize nasogastric devices.Catheter stabilization device non-sterile.Ready to use.Catalog number, lot number and use by 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.Nasogastric 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: g.H11: section a through f - the information provided by bard represents all of 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 bard.
Event or Problem Description
It was reported that the clinician was using the nasogastric stabilization device to secure a dobhoff tube that had a smaller lumen for long term feedings.The manufacturer and catalog number of the dobhoff tube was unknown.It was reported that when the clinician found the patient expired, the stabilization device tape was still secured to the patient's nose, but the tube was no longer attached, and the patient had been aspirated.The facility requested to understand if the device was approved for use with smaller lumen feeding tubes or if an alternate device should be used.Per additional information received via email on 13dec2021, the facility contact nurse stated that the cause of death was aspiration.A clinical follow up email was sent to complainant on 17dec2021 requesting additional event and patient details.A follow up email response was received on 20dec2021 from the complainant stating he does not have any additional information to provide.Despite good faith efforts no additional information has been obtained.

• Brand Name: NASOGASTRIC STABILIZATION DEVICES,STATLOCK®,ATTACHED SKIN PREP
• Common Device Name: STATLOCK DEVICE
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13025674
• Report Number: 1018233-2021-08170
• Device Sequence Number: 1727441
• Product Code: KMK
• UDI-Device Identifier: 10801741076173
• UDI-Public: (01)10801741076173
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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?: 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: 11/18/2021
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 12/17/2021
• Supplement Report FDA Received Date: 08/16/2022
• 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: Death
• Patient Sex: Unknown