MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY

Model Number	101/870/060CZ
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes bluselect malfunctioned.When the customer attempted to check the cuff's air pressure during the use of the product, he noticed the inflation line was detached from the pilot balloon.No patient injury.
Additional Manufacturer Narrative
Investigation completed on a smiths medical tracheostomy|pvc - portex tubes bluselect.The sample on complaint form used was pn:101/870/060cz.But the actual complaint is about pilot balloon which is part of tijuana subasassy pn:10009163-001.The following report will be focus in this subassy.Visual inspection from 12 -16 revealed pictured the inflation was detached from the pilot balloon.Sme reviewed manufacturing documents by engineering from tijuana which revealed testing passed 100%.This is based on a secondary assessment after viewing smiths medical czech republic production was identified with no similar trends.Based on the information provided in the complaint description, it is most likely that the unit was damage once it left shm since manufacturing performs a 100% inspection of the device for damage in different parts of the process and quality performs an inspection on a representative sample of each lot, it is even reinspect at another smh manufacturing site.A theory of bonding issue may be cause.
Event or Problem Description
Investigation completed.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 10482238
• Report Number: 3012307300-2020-08947
• Device Sequence Number: 14468196
• Product Code: BTO
• UDI-Device Identifier: 15019517076196
• UDI-Public: 15019517076196
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: No Information
• Device Model Number: 101/870/060CZ
• Device Catalogue Number: 101/870/060CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1