MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S PORTEX BLUSELECT SUCTIONAID TRACH TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	101/893/080
Medical Device Problem Codes	Inflation Problem (1310); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that during pre-test it was not possible to inflate the cannula balloon, it had a leak.There was no patient involvement, reported harm or medical intervention required.
Additional Manufacturer Narrative
Investigation codes: updated investigation summary: one used decontaminated sample 10009163-004 8mm deht blu suctionaid sub-assy was returned for investigation without its original packaging.Under visual inspection we noticed a tear in 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 is not even possible to inflate cuff as it leaks so badly.There is a hole in the cuff.History of internal ncrs showed that there was raised internal nonconformity report ncr1826 due to cuff tear which was found after inflation test.Corrective actions have been taken including initiation of quality alert, training of whole production during production town hall meeting, replacement of gauges and equipment with sharp edges by blunt versions, warning in manufacturing procedure and establishing better organization on affected workplace.No trend of confirmed complaints in relation with this issue was identified, cuff tear prior use is reported rarely, by implementation of actions from ncr1826 we reduced the likelihood of such a failure.No trend of similar customer complaints was identified.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX BLUSELECT SUCTIONAID TRACH TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 19644875
• Report Number: 3012307300-2024-05653
• Device Sequence Number: 6632766
• Product Code: JOH
• UDI-Device Identifier: 15019517103571
• UDI-Public: (01)15019517103571(17)270318(10)4449513
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K173912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 101/893/080
• Device Lot Number: 4449513
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown