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

Model Number	8.0 MM
Medical Device Problem Codes	Partial Blockage (1065); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation of this complaint was limited because no sample was returned.Customer is claiming that it was not possible to pass guidewire trough needle.It is possible that customer tried to insert guidewire directly into needle which is not correct procedure.As per instructions for use as10000115-002 rev.100 guidewire shall be inserted into needle cannula: "14) ease the guidewire introducer out from its sheath and straighten the "j" tip, leaving a sufficient length of exposed guidewire (2 - 3 cm) to enable its dispensing with the forefinger and thumb [fig.6].Insert the introducer into the cannula and feed the guidewire out of the sheath until at least 10 cm of its lies in the trachea [fig.7], leaving about 30 cm free externally." unfortunately without the sample we are not able to determine true root cause of this issue.
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes pdt griggs malfunctioned, which could cause serious injury and compromise of airway management.The report stated "during the tracheotomy, it was found that the guide wire elbow could not pass through due to the improper anastomosis between the front end component of the guide wire and the puncture needle, and the tracheotomy could not be completed.Emergency replacement of cvc puncture needle and guidewire, then operation completed." no further information.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• MDR Report Key: 11399350
• Report Number: 3012307300-2021-01660
• Device Sequence Number: 14298348
• Product Code: BTO
• UDI-Device Identifier: 15019315106606
• UDI-Public: 15019315106606
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060945
• 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
• Report Date (Section B): 03/02/2021

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: Health Professional
• Device Expiration Date: 06/19/2024
• Device Model Number: 8.0 MM
• Device Catalogue Number: 100/541/080CZ
• Device Lot Number: 3817700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2021
• Initial Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR