MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PVC - PORTEX TUBES BLUE LINE ULTRA (BLU); TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/811/070CZ

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.No problem or issues were identified during the device history record review.Investigation of this complaint was done based on received photos.Visual inspection of the photos showed one open shelf carton with tube holder and cleaning brush inside carton.Each work order is sample inspected by quality department prior release to sterilization.The history of internal non-conformities and complaint history was checked and no trend of similar incidents was identified.Reported missing component is considered to be isolated incident only.Root cause remains unknown.No action taken.

Event Description

It was reported that one of the units has an item of the kit missing.It is a 2 part kit and the brush and strap are missing from the kit.Device was not in use with patient.Pickup of the device for investigation will be arranged.No patient injury reported.

• Brand Name: PVC - PORTEX TUBES BLUE LINE ULTRA (BLU)
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 16873827
• MDR Text Key: 314617905
• Report Number: 3012307300-2023-05130
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/811/070CZ
• Device Lot Number: 4170871
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1