MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SILICONE - BIVONA TUBES ADULT TTS; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 670180

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.Pictures attached in investigation: 2 images were provided.One (1) sample was received in used conditions, without its original packaging.The sample was tested on leak test.The test was performed under water symmetry and leak test method.During the test, a leak was found in the cuff.The cuff was inspected using a digital microscope with a scale of 200x, to observe better the shape of the pinhole found during leak test.The hole was observed with a circular shape with flash in the periphery.The root cause of the reported issue was found to be most probable that the damage occurred after the product left the manufacturing facilities.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

Event Description

It was reported that the cuff was leaking during pre-test.No patient injury was reported.

• Brand Name: SILICONE - BIVONA TUBES ADULT TTS
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 16857893
• MDR Text Key: 314452332
• Report Number: 3012307300-2023-04945
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312006070
• UDI-Public: 15021312006070
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 670180
• Device Catalogue Number: 670180
• Device Lot Number: 4026724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1