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

Catalog Number 100/810/080

Device Problems Nonstandard Device (1420); Gas/Air Leak (2946)

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

Event Type  malfunction  

Manufacturer Narrative

Device evaluation, including root cause analysis, is in progress.No product was returned for investigation.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 the mexico government sales area received a non-compliance report, dated on (b)(6) 2022, regarding a pvc portex blue line ultra disposable tracheostomy cannula with catalog no.100/810/080 and lot #: 4059501, sanitary registry: (b)(4).The (b)(4)bidding event involves 41 pieces of the aforementioned device.8 pieces were analyzed by the laboratory of non-metallic materials of the division of healing materials and instruments of the (b)(4) , which found that the samples of the product did not comply with the quality specifications of the cnis (national compendium of health supplies) and the feum-sdm-2017-4ed; finding discrepancies in the internal and external diameters of the cannula (with values higher than those specified in the reference monograph) the endocanula internal diameter specification was 8,0 +/- 2 mm and was found to have 8,3 mm.The external diameter specification was 11,3 +/- 0,5 mm and was found to have 12,1 mm.The samples also presented leakage in the balloon of the cannula and its pilot balloon.Additional information received via email on 21-oct-2022: of the 8 pieces chosen, none of them meets the measurement standards in terms of internal and external diameter of the input, established in the supplement for medical devices, fourth edition of the pharmacopoeia of the united mexican states, mexico 2017.The tests are carried out on the balloons, found leaks in the balloon in 3 pieces and in the pilot balloon in 2 pieces.With these results, the rest of the tests established in the feum for the input were suspended and the entire batch was declared as not compliant.A picture of a table with the tests results was attached to the complaint object.No patient injury was reported.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: device evaluation was completed.No product was returned for investigation.Three (3) pictures were attached and reviewed.Picture one shows a table of cannula dimensions ranges for multiples cannula sizes.Picture two is not clear.Picture three shows the cuff line connected to a syringe and bubbles are visible.Per the attached image leakage complaint is confirmed.Functional testing: no product was returned for analysis.We are unable to confirm the reported complaint.The root cause cannot be determined since no device was retuned for analysis.If the product is returned, the manufacturer will reopen this complaint for further investigation.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• Brand Name: PORTEX TUBES BLUE LINE ULTRA (BLU)
• 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): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; barrio san lucas; minneapolis, MN 55442
• MDR Report Key: 15730313
• MDR Text Key: 307576841
• Report Number: 3012307300-2022-26687
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/810/080
• Device Lot Number: 4059501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1