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

Device Problems Deflation Problem (1149); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

Evaluation results: one used bivona tracheostomy tube (part number 670160-sa) was received with its certificate of safe handling.An obturator from the bivona pediatric tubes was also received with the sample.Visual inspection was performed at 12 inches under normal lighting to look for any damages on the cuff.A white substance was found inside the pilot balloon.The unit was inflated with water to see if there were any problems with the inflation of the cuff.When inflating the unit, it was noted that the pilot balloon inflated, however all the water was stuck.The cuff was burst open to see if the airway line was occluded.No occlusions were found.The unit was then inflated with air.All the air was once again stuck in the pilot balloon.The airway line was subsequently cut using a razor, and a wire was passed through the inflation line to check for any occlusion.After cutting the line, a particle was found inside the inflation line.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The most probable root cause identified for this complaint is as follows.The reported issue/damaged occurred after the product left the manufacturing facility.As a preventive action, production personnel were notified by the quality engineer on (b)(6) 2019 of the reported customer complaint.

Event Description

It was reported that the customer had issues with the tracheostomy (trach) cuffs.The customer was only able to reinflate one of the cuffs with 2 ml of water, which is half the volume that was initially used.With respect to the other cuff, the customer observed that it was completely deflating.A trach change out was performed as a result of the product issues.No patient injury or further complications were reported in relation to this event.It was further reported on (b)(6) 2019 that the patient's mother had coated the shaft of the tracheotomy with vaseline prior to insertion.Vaseline is not a water soluble product.The instructions for use (ifu) call for the use of only water soluble products.

• Brand Name: BIVONA
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 8923204
• MDR Text Key: 155319630
• Report Number: 3012307300-2019-04230
• Device Sequence Number: 1
• Product Code: JOH
• 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
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Date Manufacturer Received: 02/19/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 17 YR