MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY

Model Number	101/860/085CZ
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes bluselect malfunctioned.The customer confirmed that the product worked properly in a pre-use check.However, during the use of the product, the customer noticed the inflation line got detached from the pilot balloon.No patient injury.
Additional Manufacturer Narrative
Other, other text: one used decontaminated sample 10009163-005 8.5mm deht blu suctionaid sub-assy was received in plastic bag without its original packaging (see photo of sample).Under visual inspection we noticed that pilot balloon was detached from inflation line.10001429-005 infl.Line s/assy soft-seal 8.5mm is assembled in smiths medical tijuana therefore secondary investigation object in-0099123 was created and complaint sample was resent to this site.
Event or Problem Description
Investigation completed and summary.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• MDR Report Key: 11387139
• Report Number: 3012307300-2021-01599
• Device Sequence Number: 11606120
• Product Code: BTO
• UDI-Device Identifier: 15019517076165
• UDI-Public: 15019517076165
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: No Information
• Device Model Number: 101/860/085CZ
• Device Catalogue Number: 101/860/085CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 07/21/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 08/19/2021
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1