MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; DILATION TRACHY KIT

Model Number	100/562/000CZ
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer states the cannula often kinks when they try to put the guidewire through cannula.It was reported the actual device has not been used on a patient.But was also stated to have occurred while in use with a patient.Clarification has been requested.No patient injury occurred.
Event or Problem Description
Customer states the cannula often kinks when they try to put the guidewire through cannula.The actual device has not been used on a patient.
Additional Manufacturer Narrative
Other, other text: investigation received on a smiths medical tracheostomy|pvc - portex tubes pdt ultraperc.The device of unused component good kit 100/562/000cz in plastic bag.Under visual inspection, the component finish good kit 100/562/000cz revealed broken as photo attached.During replication the event was duplicated and verified.The hypothesis is very unlikely the quidewire caused event as this is very soft.It is believed probable source is damage due to reinsertion of needle back into cannula.When it is done when cannula is slightly bent there is risk that tip of needle damage inside surface of cannula.Such reinsertion is forbidden as per instructions for use as10018928-001 rev.100 point 5.8: "once the needle has been partially or completely withdrawnfrom the cannula, never re-insert it as this could result in the catheter being cut and left in the trachea." unfortunately such scenario cannot be 100% confirmed therefore root cause of this issue remains unknown.

• Brand Name: PORTEX
• Common Device Name: DILATION TRACHY KIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• MDR Report Key: 10587688
• Report Number: 3012307300-2020-09823
• Device Sequence Number: 13763229
• Product Code: JOH
• UDI-Device Identifier: 15019315106750
• UDI-Public: 15019315106750
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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): 11/23/2020

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: 100/562/000CZ
• Device Catalogue Number: 100/562/000CZ
• Device Lot Number: 3980269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 09/25/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1