MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PVC - PORTEX TUBES PDT ULTRAPERC; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	100/562/000CZ
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the guidewire does not fit in the needle.The red introducer could not properly straighten the round end of the guidewire.The cannula was not inserted with the needle.There was an increase of procedure's duration, patient's bleeding and mechanic ventilation.
Additional Manufacturer Narrative
Other text: this mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).Investigation of this complaint was limited because no sample nor photo was provided.Similar product which was manufacture around the same date and was returned for another complain was used to do testing.Components were assembled as per instructions for use and there were no problem observed during assembly and testing.Based on complaint description it is possible that customer tried to connect straightener with needle itself and then load guidewire inside the needle.Insertion of guidewire directly into the needle is not in compliance with instructions for use and might lead exactly to the same failures as described by customer.Unfortunately without the sample we are unable to determine true root cause of this issue.The root cause of the reported issue was not able to be determined.Actions were taken to mitigate the reported issue: none.No problems or issues were identified during this device history record review.E4: initial reporter also sent report to fda is unknown.

• Brand Name: PVC - PORTEX TUBES PDT ULTRAPERC
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16919447
• Report Number: 3012307300-2023-05610
• Device Sequence Number: 15183514
• Product Code: JOH
• UDI-Device Identifier: 15019315106750
• UDI-Public: 15019315106750
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 4133611
• 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: 02/15/2022
• Initial Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown