MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 60PFSS35

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2022

Event Type  Death  

Manufacturer Narrative

Other, other text: device evaluation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Udi#: unknown.No lot or serial numbers were communicated; device expiration date and h4: device manufacturing date not available.

Event Description

It was reported an accidental decannulation, cardiorespiratory arrest and subsequent death.Customer reported the incident occurred in (b)(6) 2022, ultimately the tracheostomy tube from this complaint is being held by the police and that the mhra (medicines and healthcare products regulatory agency) and coroner's office have been informed.

Event Description

Additional information was received.The device remains with the police.The police have also taken possession of 5 other tracheostomy tubes belonging to the same patient that were previously returned to the community nurse.These therefore cannot be retuned at present.It has been relayed this to the police of the need to review the tubes and investigate as a matter of urgency.Additionally, the accidental decannulation was not witnessed.The patient was sleeping and was left unattended for about 5-10 minutes.When the patient mother returned, the child was unresponsive with the trach tube broken at the flange.The flange was entirely separated from the tube.The tube had been routinely changed the previous 24 hours and was secured with velcro ties.

Manufacturer Narrative

Other, other text: b5: describe event or problem; d4: catalog number and h6.Event problem and evaluation codes: updated.No actual product was returned however, thirty (30) photos were provided for analysis which identified a part number and two (2) lot numbers.It is not known which photos are related to this complaint.Photo analysis showed the flange component was broken, confirming the complaint.After a review of the different verifications that are performed by product personnel during the manufacturing process to detect damaged components, the most probable root cause is that damage occurred after the product left the facility.Since it is unknown which of the identified lot numbers is for this event, a device history record (dhr) review was conducted for both lot numbers, and did not identify any non-conformances or related issues during the manufacture of the reported lot number.A customer complaint notification was made to raise awareness of the reported issue, conducted march 2023.

Event Description

The suspected lot numbers were 4075238 and 3767405.

• Brand Name: SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16229979
• MDR Text Key: 307955044
• Report Number: 3012307300-2023-00620
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60PFSS35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 5 YR
• Patient Weight: 20 KG