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

Lot Number 3400954

Device Problem Break (1069)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that there was a split flange.No harm to the patient.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.A sample was received for evaluation.The sample was received in used condition, without original packaging and with its certificate of safe handling.The sample was visually inspected under normal lighting to received unit.During visual inspection, condition reported in complaint is visible; however, this does not assure us that there is still a failure of the process, since mishandling by the user by not adjusting the tracheostomy device correctly could cause the rupture.Based on this, the failure mode cannot be confirmed.Based on the tests performed to replicate the failure mode, where it could not be reproduced using the tools from assembly process, the most probable root cause is that damaged occurred after the product left manufacturer.No corrective actions were taken.D4 and g5 are unknown.

Event Description

Additional information: received via email 15-nov-2021: date of event is unknown, occurred while in use with a patient, but was resolved by changing out the device.Patient information updated.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 12628854
• MDR Text Key: 276354641
• Report Number: 3012307300-2021-09952
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2023

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 Expiration Date: 06/01/2022
• Device Lot Number: 3400954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 05/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Female