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 03/03/2021

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 statlock holder not secured the tube and the tube migrates or pulls out, which needed replacement and doesn't stick to the nose.

Event Description

It was reported that statlock holder not secured the tube and the tube migrates or pulls out, which needed replacement and doesn't stick to the nose.Per follow up on 06jun2021, customer stated that the problem seems to be that the adhesive wrap did not encircle to tube as much as our previous product did.So once the patient had discharge from the nose, it loosens the adhesive portion around the tube even though we use alcohol prior to placement and then the tube becomes dislodged.This had happened multiple times and previous product wrapped around the tube multiple times so if some adhesion did loosen, it was still able to stay in place.

Manufacturer Narrative

The reported event was inconclusive.A potential root cause for this failure could be due to "incorrect design of diameter at the end of the lumen or inadequate material selection during design phase".The device was not returned for evaluation.The lot number is 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.Product code, lot number and expiration date information¿see packaging.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.Rx only.Latex free 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." 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.

• 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
• MDR Report Key: 11567921
• MDR Text Key: 242643510
• Report Number: 1018233-2021-01579
• Device Sequence Number: 1
• Product Code: KMK
• UDI-Device Identifier: 10801741076173
• UDI-Public: (01)10801741076173
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/25/2021
• Supplement Dates Manufacturer Received: 06/12/2021
• Supplement Dates FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other