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

Catalog Number 100/800/060CZ

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that there is lots of moisture inside the tube.No injury reported.It was discovered prior to patient use.The outcome of the event was resolved.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.10 not used (not opened) unit packs were returned for investigation.Under visual inspection the samples appeared to be in good condition.There was not any moisture inside unit packs.Following packaging testing was performed: dye test was performed on 5pcs.All 5 pcs passed the testing (whole packaging including seal was leak proof).Peel test was performed on 5pcs.All 5 pcs passed the testing (seal was continuous and met width limit).Based on physical testing the sterile barrier (unit pack) was evaluated as acceptable and there was not found any packaging related nonconformity.Possible explanation of customer observation is that transparent film of unit pack is slightly fuzzy.That might be incorrectly evaluated by customer to be moisture.Despite that transparent film is within all specifications and its visual appearance is normal (in comparison with current and older production).Any similar customer complaint has not been ever received against product.The cause of the reported problem could not be determined as no fault was found with the device.A manufacturing dhr (device history review) was not performed because the results of the complaint investigation do not indicate a problem with the manufacture or last repair of the device.No manufacturing or service issues were identified as causes of the customer reported problem during the review of service and repair records.Therefore, no manufacturing or service records review is needed.

• Brand Name: 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; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; seongbuk-gu; minneapolis, MN 55442
• MDR Report Key: 16014788
• MDR Text Key: 308149029
• Report Number: 3012307300-2022-27978
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/800/060CZ
• Device Lot Number: 4121503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1