MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® ENDOBRACHEAL TUBE; TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)

Model Number 198-32L

Device Problem Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Event Description

Information was received indicating that during intubation of a patient with a smiths medical portex® endobracheal tube, difficulty was met.It was reported that the degree of curve to the tube's tip was noted to be varied.There were no reported adverse effects.

Event Description

Investigation completed on a smiths medical intubation|portex endobronchial tubes.

Manufacturer Narrative

Investigation completed on a smiths medical intubation|portex endobronchial tubes .Products from p/n 198-37l l/n 3666522; the returned samples were received in new conditions with their original closed packaging.No discrepancies were revealed in the tip of the tube upon visual inspection 12"-16" with no discrepancies observed with the tip of tube.Pictures were sent to confirm this issue on 22/may/2020 p/n 198-35l l/n 3977828 an audit was done with quality engineer and device passed 100%.The root cause is hypothesized as lack of detection with personal in production and damage to product after leaving shm facilities, since product is 100% inspected with the fixture eng-0292-t008.Action was taken to train the production personnel in the procedure pict 0068 rev.107 stylet bender and assembly (ebt area) by quality engineer on 29/may/2020.

Manufacturer Narrative

Other, other text: one unused sample was returned to perform an investigation.The returned sample was visually inspected at a distance of 12 to 16 inches under normal conditions of illumination and no discrepancies were observed with the tip of the tube.The reported problem was confirmed.An audit of the production floor was conducted by a quality engineer.Units were sampled during this audit and no discrepancies in the orientation of the tube were detected.The results of the audit found that operations were being performed properly by trained operators.It was determined that the most probable root cause is related to lack of detection by production personnel or that the product become damaged after it left the manufacturing facility.Training of the production personnel was conducted by the quality engineer.D5 is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX® ENDOBRACHEAL TUBE
• Type of Device: TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, mn
• Manufacturer (Section G): NULL; 6000 nathan lane n; minneapolis, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, mn ; 3833310
• MDR Report Key: 10029171
• MDR Text Key: 190015110
• Report Number: 3012307300-2020-03787
• Device Sequence Number: 1
• Product Code: CBI
• UDI-Device Identifier: 15019315058608
• UDI-Public: 15019315058608
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K953483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/01/2022
• Device Model Number: 198-32L
• Device Catalogue Number: 198-32L
• Device Lot Number: 3843147
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1