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

Model Number 67PFSS35

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 12/10/2018

Event Type  malfunction  

Event Description

It was reported that patient's mother was inspecting the trach, a visible hole was noticed in the cuff.No patient injury was reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).An invalid lot number was provided; therefore, device history record review could not be completed.A product sample was received for evaluation.Visual and functional testing were performed.One (1) sample was received without its original packaging inside a ziploc bag.Sample was in used conditions.Visual inspection was performed at 12 under normal lighting to received units, in order to detect any damage on the cuff or airline.During the visual inspection, it was found exposed wire on the shaft.The sample was tested on leak test.The test was performed under water as per procedures.In order to see if the unit had a hole.The unit was inflated and it was visually inspected for 10 seconds, it was not observed any leakage and it was seen well inflated.Then the unit was submerged under water, it was not observed any leakage.It was followed to massage the product, the balloon was squeezed and the airway line was moved back and forth, no leakage was detected.Additional in attempt to reproduce the failure mode a sample was taken from scrap process and the dremel was used on the surface of the tube to remove the silicon excess.During the test, it was observed that if the dremel was not used properly the surface of the tube could be damaged and the exposed wire could appeared in a similar way to the sample received, which was the root cause of the reported event.Production personnel reviews the parts 100% before assembling and after assembling them to see if they any exposed wire.Quality takes a representative sample and performs a visual inspection reviewing for wire at shaft after process.Qalert was generated in order to ensure that operators could be able to see how to inspect the tubes to detect exposed wire.Create visual aid to show the correct procedure to position /adhesive shaft into neckstrap and how to use the dremel.Changed was initiated.Updated to reference the visual aid.Changed was initiated.As a preventive action production personnel was notified by area trainer as awareness of the defect reported by the customer.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15625268
• MDR Text Key: 307002256
• Report Number: 3012307300-2022-24824
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 10351688518682
• UDI-Public: 10351688518682
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923878
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2018
• Device Model Number: 67PFSS35
• Device Catalogue Number: 67PFSS35
• Device Lot Number: 363556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• 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