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

Catalog Number 100/860/080CZ

Device Problem Material Puncture/Hole (1504)

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

Event Type  malfunction  

Manufacturer Narrative

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.No product information has been provided to date.

Event Description

It was reported that upon opening the package, the customer found that the cuff was punctured.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.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.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: device evaluation: the device was returned for investigation.During the manufacturing process the devices are 100 percent inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.The inflation test was repeated on the received sample.It was found that it is not even possible to inflate cuff as it leaked so badly.Source of leak was identified by water testing to be hole in cuff.The cause of the reported issue was traced to manufacturing.Corrective actions have been taken including initiation of quality alert, training of whole production during production town hall meeting, replacement of gauges and equipment with sharp edges by blunt versions, warning in manufacturing procedure and establishing better organization on affected workplace.A review of the device history records shows there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBES
• 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; tambore ? santana de; minneapolis, MN 55442
• MDR Report Key: 15520887
• MDR Text Key: 306270446
• Report Number: 3012307300-2022-20590
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/860/080CZ
• Device Lot Number: 3869482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 09/30/2022
• Supplement Dates Manufacturer Received: 10/24/2022; 04/10/2023
• Supplement Dates FDA Received: 11/04/2022; 05/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1