MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUE LINE ULTRA SUCTIONAID TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/870/080CZ

Device Problem Defective Device (2588)

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

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

(udi) is unknown; no additional information was provided.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A review of the device history records (dhr) showed there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.One decontaminated product sample was received for investigation with its original packaging.Under visual inspection the sample appeared to be in good condition.The inflation test was repeated on the received sample.It was observed that it was not even possible to inflate the cuff because it leaked so badly.Then the sample was submerged into water and cuff was inflated.Air leak from cuff caused by 2mm long tear was identified.The root cause was deemed to be manufacturing-related.The affected batch was manufactured in february 2019.Since this time, several corrective actions have been implemented with purpose to reduce possibility of cuff damage after inflation test.

Event Description

It was reported that, during a pre-use check on the product, the cuff did not inflate; therefore, it was not used.No patient injury was reported.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15600018
• MDR Text Key: 307030962
• Report Number: 3012307300-2022-23896
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/870/080CZ
• Device Lot Number: 3740961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1