MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX ENDOTRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/126/025
Medical Device Problem Codes	Component Incompatible (1108); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation on progress.
Event or Problem Description
The customer reported the following product problem.The issue was related to the endotracheal tubes not all being the same length.The customer noticed that they were cut at different positions which caused the inline suction catheters to not be inserted to the desired depth.The customer believed that it was not a true product failure, as the endotracheal tube still provided a patent airway to the patient for intubation.The customer noted that it was just not a standard cut where the tube was attached to the hub of the connector.The customer adjusted the position of the inline suction catheter insertion so that they could clear the patient's airway, and have the catheter go to the proper depth.No patient injury or complications were reported in relation to this event.
Additional Manufacturer Narrative
Device evaluation: the sample consist of two (2) products from p/n 60748 wit lot number reported as unknown; the returned samples were received in used conditions inside a plastic bag without their original packaging.Visual inspection: the samples were visually inspected at a distance of 12" to 16" under normal conditions of illumination.Results: no discrepancies were observed.Testing: the length of the sample was measure with a rule, cal i.D.13.0687 due date: april 2021 results: the tube measure was of 114 and 116 mm, the tubes are within spec according to mp tpln-tj070 rev 101 tracheal plain - cut length and assemble connector to tracheal tube, the dimension must be 113 ± 3 mm.Production personnel inspect 10 samples at start of order, shift change or resets to ensure that the cut length of the tube is correct.Quality takes a sample using an aql 1.0 and level inspection g-i in order to verify the length of the tube.Costumer reported: "trach tubes were cut at different locations.Causing the inline suction catheter to be moved back in the airway and change the location of the suction catheter for proper suctioning." no root cause needs to be determined since the complaint was not confirmed due to no issues were found with the smh product.No corrective actions are required since the complaint was not confirmed; however, a notification of a complaint regarding to the failure mode to the production personnel was conducted by quality engineer on 07/feb/2020 as awareness of the defect reported by the customer.
Additional Manufacturer Narrative
Other text: no lot number was provided; therefore, device history record review could not be completed.The sample was returned for evaluation.The sample consist of two (2) products with lot number reported as unknown.The returned samples were received in used conditions inside a plastic bag without their original packaging.The samples were visually inspected at a distance of 12 inches to 16 inches under normal conditions of illumination and no discrepancies were observed.The length of the sample was measured and the tubes were within specifications the reported problem was not confirmed.The root cause is not needed to be determined since the complaint was not confirmed due to no issues were found with the product.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: PORTEX ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; boundary road; hythe, ; UK
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; mn, MN 55442
• MDR Report Key: 9593787
• Report Number: 3012307300-2020-00285
• Device Sequence Number: 16236829
• Product Code: BTR
• UDI-Device Identifier: 15019315056758
• UDI-Public: 15019315056758
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2022

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
• Operator of Device: Other
• Device Model Number: 100/126/025
• Device Catalogue Number: 100/126/025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 02/18/2020; 04/21/2022
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/20/2020; 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown