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

Catalog Number 100/860/075

Device Problem Suction Problem (2170)

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

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Udi is unknown.No information provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms#: 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.A product sample was received for evaluation.Visual and functional testing were performed.The sample was visually inspected, at a distance of 12? to 16? and normal conditions of illumination.The investigation observed the suction line was detached.20 samples were taken from the production floor of which 10 were applied tetrahydrofuran (thf) in excess and 10 followed their normal process.During evaluation testing, the reported issue was noted in all cases of the samples that had the excess of tetrahydrofuran (thf) the detachment occurred in the flange as in the received sample, in the case of the samples that did not have the excess of thf the detachment occurred under the flange and in two cases the detachment did not occur also requires more force to cause detachment.The root cause of the reported issue was excess tetrahydrofuran that was applied and lack of detection by production personnel during manufacture.Actions were taken to mitigate the reported issue: production personnel were retrained to process and procedure by the production supervisor.

Event Description

It was reported that during the use of the product, the customer noticed they could not suck through the suction line.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: 15598981
• MDR Text Key: 306819533
• Report Number: 3012307300-2022-23878
• 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: Health Professional
• 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: 100/860/075
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2022
• 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