MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number 60NFP30

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

D4: lot number, full udi number, expiration date and h4: manufacture date are unknown; no information has been provided to date.E1 additional phone number: (b)(6).Device evaluation: one sample was received in used condition without original packaging.Per visual inspection, it was detected that one tube was broken in two parts (sample related to the reported part number), the wire was stretched.The complaint was confirmed.The lot number was unknown, therefore no device history report (dhr) review could be completed.This type of condition could be generated during use in the patient by stretching the product with excessive force or during reprocessing of sample for subsequent uses due to improper handling or use of non-recommended lubricants or cleaning solutions that could damage the product.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.The failure mode will continue to be monitored.

Event Description

It was reported that the trach hub was disconnected from the flex end piece of the trach.The trach was in the stoma, wings secured with trach ties.Coil from flextend piece was extending outside of the trach extend piece.The trach was removed and placed in ziplock bag and left at bedside for pick up.New bivona 3.0 cuffless flextend placed.It was stated that the fault occurred while in use with patient.The event occurred in the hospital.Patient adverse effects are unknown.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18803658
• MDR Text Key: 336509060
• Report Number: 9617604-2024-00189
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60NFP30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention