MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 101/870/080

Device Problem Material Puncture/Hole (1504)

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

Event Date 01/02/2024

Event Type  Injury  

Event Description

It was reported that during the "cz-hi" injection, the patient called the nurse to complain of bloating.When the nutrition was finished, the pilot balloon was checked and yellow liquid was stored in the pilot balloon.The operator reported it to the head and neck surgeon doctor.The dr.Said that if there was no hole in the cuff, the fluid would not enter, but if there was a hole, the pilot balloon should deflate.Due to the abnormal situation, the cannula was replaced.When the operator checked the removed cannula, there was a hole in the cuff found.At 8:20, the "pilot balloon shook to confirm, but there was no air leakage and no fluid accumulation".There was no adverse event or harm reported.

Manufacturer Narrative

Lot number, expiration date, d5: operator of device, and h4: manufacture date are unknown; no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Investigation summary: one used decontaminated sample was returned for investigation without its original packaging.Under visual inspection a tear was noticed in the cuff.During manufacturing process, the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12-hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.The inflation test was repeated on the received sample.It was found that it was not even possible to inflate the cuff as it leaked so badly.Due to fact that cuff leak was not observed prior to use it is most probable that the reported failure occurred during the tracheostomy procedure or during use due to contact with a sharp edge.A device history record could not be completed as no lot number was received.

• Brand Name: PORTEX BLU SELECT SUCTIONAID CUFFED TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18654787
• MDR Text Key: 334723172
• Report Number: 3011237704-2024-00035
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 101/870/080
• Device Catalogue Number: 101/870/080CZ
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/04/2024
• Date Manufacturer Received: 02/09/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention