MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL FLEXTEND BIVONA TUBES CUSTOM; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number FT18DN65NSC129S

Device Problem Misconnection (1399)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Photos provided and used to evaluate the device.Picture of the swivel connector shows that the ledge of the connector was broken.The possible causes of a broken connector are the improper use of the disconnect wedge, excessive force applied to secure the accessory to the connector, distortion of the connector due to applied heat during cleaning or sterilization, dropping the device and causing a stress fracture, and attempting to remove the swivel when cleaning the device.Picture of the shaft highlighted the cuff band.The cuff band is used to secure the cuff to the shaft.It is applied on top of the cuff and adhesive is applied underneath the band and on top of the band.The adhesive is then smoothed to taper the adhesive joint.There will be a bulge / slight bump visible on the shaft.This is normal.The bulge / slight bump is more noticeable with a tts cuff, which is the type of device the complainant uses.Based on the picture, the bulge / bump does not appear to be excessive or to be considered a manufacturing defect.Without the benefit of a returned sample, a manufacturing defect could not be confirmed for the broken connector or the bulge on the shaft.The reported complaint was not confirmed.While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

Event Description

Information was received that the swivel connector was too tight on a smiths medical tracheostomy tube.Inhalation or ventilation are extremely difficult to remove, and the ring broke as a result.A bulge was noted in the cannula at the point where the tts cuff starts, so that the caregivers with the suction catheter did not get into the cannula.No patient injury occured.

• Brand Name: SMITHS MEDICAL FLEXTEND BIVONA TUBES CUSTOM
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue; gary IN 46406
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8906412
• MDR Text Key: 154739606
• Report Number: 3012307300-2019-04043
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15019517148916
• UDI-Public: 15019517148916
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/12/2023
• Device Catalogue Number: FT18DN65NSC129S
• Device Lot Number: DS017653
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2018
• 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
• Patient Outcome(s): Required Intervention