MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUPERC PERCUTANEOUS DILATION PROC. KIT WITH SINGLE STAGE DILATOR, 8.0 MM; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	101/563/080
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
H6.Evaluation codes: updated.The investigation of this complaint was done based on a photo as the device was not received for physical analysis.On the photo there is a cracked suction connector.The root cause is unknown as it could be a molding defect or excessive force used when the connector was connected with syringe during use.No trend of confirmed customer complaints was identified in relation to this issue.A device history record (dhr) review reported no discrepancies or non-conformance's during the manufacturing of the reported lot number.If the product is received the manufacturer will re-open the complaint for further device analysis.

• Brand Name: PORTEX BLUPERC PERCUTANEOUS DILATION PROC. KIT WITH SINGLE STAGE DILATOR, 8.0 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: 19221990
• Report Number: 3012307300-2024-03224
• Device Sequence Number: 20558894
• Product Code: BTO
• UDI-Device Identifier: 15019517103410
• UDI-Public: (01)15019517103410(17)260717(10)4405218
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 07/17/2026
• Device Catalogue Number: 101/563/080
• Device Lot Number: 4405218
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/12/2024
• 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: 07/18/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2023
• 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