MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PVC - PORTEX TUBES BLUSELECT; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	101/870/075CZ
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that fourteen (14) days after staring to use the product, the customer noticed the pilot balloon was detached from the inflation line.It is unknown at which point of the day the event occurred.No trouble was observed during the use of the product.There were no patient harm or injury reported.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).No problems or issues were identified during this device history record review.One used decontaminated sample was received in plastic bag without its original packaging for investigation.Visual inspection noted that the pilot balloon was detached from the inflation line confirming the reported event.The root cause of the reported event was undetermined.

• Brand Name: PVC - PORTEX TUBES BLUSELECT
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16844495
• Report Number: 3012307300-2023-04811
• Device Sequence Number: 6870463
• Product Code: BTO
• UDI-Device Identifier: 15019517076219
• UDI-Public: 15019517076219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2023

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 Model Number: 101/870/075CZ
• Device Catalogue Number: 101/870/075CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian