MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUPERC PERCUTANEOUS DILATION PROC. KIT WITH SINGLE STAGE DILATOR, 9.0 MM; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/563/090
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
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 the suction aid port cracked, making it difficult to aspirate secretions on the patient.This potentially caused an increased risk in aspiration pneumonia."as this is someone¿s airway the device can not be changed easily.These are for the tubes that had been percutaneously inserted on different size tubes." the device was already inserted in the patient.There was patient involvement but no patient harm/adverse event reported.The event occurred in the hospital during."steps to resolve the issue: need to mark tubes and highlight the problem.Had the whole tube changed when patient was able to.Issue resolved: no.".
Additional Manufacturer Narrative
H3 and h6 - updated.No device was received for investigation.Therefore, we are unable to determine the reported complaint.If we receive the device, we will reopen the investigation for further evaluation.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: PORTEX BLUPERC PERCUTANEOUS DILATION PROC. KIT WITH SINGLE STAGE DILATOR, 9.0 MM
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19222029
• Report Number: 3012307300-2024-03227
• Device Sequence Number: 6904207
• Product Code: BTO
• UDI-Device Identifier: 15019517103427
• UDI-Public: (01)15019517103427(17)260101(10)4348866
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2024

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 Expiration Date: 01/01/2026
• Device Catalogue Number: 101/563/090
• Device Lot Number: 4348866
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 05/17/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2023
• 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