MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO

Catalog Number 60SN040JJP

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign report source: (b)(6).

Event Description

Information was received that during the use of a smiths medical bivona uncuffed neonatal and pediatric tracheostomy tube, the customer noticed a part of the flange was damaged.No patient injury.

Manufacturer Narrative

D5 is unknown.No information has been provided to date.Device evaluation: the device was returned for investigation.During the visual inspection, it was seen that the flange was broken.The reported failure was confirmed.The most probable root cause is that damaged occurred after the product left the facility.Exact root cause could not established.As a preventive action production personnel was notified by quality engineer as awareness of the defect reported by the customer.A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacturing of the device.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).

Manufacturer Narrative

Other text: additional information: no information has been provided to date.Device evaluation: the device was returned for investigation.During the visual inspection, it was seen that the flange was broken.The reported failure was confirmed.The most probable root cause is that damaged occurred after the product left the facility.Exact root cause could not established.As a preventive action production personnel was notified by quality engineer as awareness of the defect reported by the customer.A manufacturing device history record (dhr) review was not performed because the results of the complaint investigation do not indicate a problem with the manufacturing of the device.This remediation mdr was generated under protocol (b)(4).

• Brand Name: BIVONA UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR) PRODUCT CODE: BTO
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9685072
• MDR Text Key: 178326915
• Report Number: 3012307300-2020-00955
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 60SN040JJP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1