MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/543/080CZ

Device Problem Device Markings/Labelling Problem (2911)

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

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4)., as a result of warning letter (b)(4).Unique identifier and 510k are unknown.No information has been provided to date.A review of the device history records shows that during manufacturing of this batch 10 new shelf carton labels had to be additionally printed.No product sample was received; therefore, visual and functional testing could not be performed.No visual/functional testing completed on the photos there were 10 shelf cartons within one transit carton without yellow warning sticker "without forceps" plus one shelf carton from the same part number lot number was not visible with yellow sticker "without forceps" for comparison purposes.Based on information provided by customer 10pcs out of 395pcs from lot were found to be without yellow sticker.It was confirm that each shelf carton shall contain yellow sticker "without forceps" therefore manufacturing error was identified.It was the most probable that operators forgot to use yellow labels on those 10 pieces.Therefore we don't expect that more cartons will be affected by missing yellow labels.Improvements which are described in analysis section will prevent to such issues because quantity of used yellow stickers are now fully under control.This customer's complaint was introduced to all employees on monthly town hall meeting.

Event Description

It was reported that the round yellow sticker was missing.No patient injury was reported.

• Brand Name: PORTEX TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15604532
• MDR Text Key: 307173355
• Report Number: 3012307300-2022-24014
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/543/080CZ
• Device Lot Number: 3637895
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• 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