MAUDE Adverse Event Report: BSN MEDICAL TENSOPLAST TAPE 1IN X 5YDS STRETCHED; TAPE AND BANDAGE, ADHESIVE

Catalog Number 02114-00

Device Problems Disconnection (1171); Device Dislodged or Dislocated (2923)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/11/2022

Event Type  malfunction  

Event Description

All neonatal intensive care unit (icu) endotracheal tube (et) tube holders were recalled and as such, we had to remove them from stock immediately.Et tube holders were changed to elastoplast tape for security.Infant noted to be desaturating on monitor.Upon examination she was very dusky with rapidly decreasing heart rate and spo2 reading.Determined infant self-extubated and oscillator became disconnected which ended all respiratory support.Heart rate fell to low of 40 bpm and spo2 23%.New ett securement tape was no longer sticky and came off infant's face leading to ett dislodgement.Immediately enlisted aide of 2 additional rn's, 1 rt, and 2 fellows on duty.Ppv began and continued through successful re-intubation.Immediate chest/abdomen x-ray obtained to confirm placement.Infant without adequate oxygenation for this 16- minute event.

• Brand Name: TENSOPLAST TAPE 1IN X 5YDS STRETCHED
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): BSN MEDICAL; 5258 carnegie blvd; charlotte NC 28209
• MDR Report Key: 15904437
• MDR Text Key: 304693504
• Report Number: 15904437
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 02114-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 DA
• Patient Sex: Female
• Patient Weight: 1 KG