MAUDE Adverse Event Report: ST PAUL PORTEX; NASAL INTUBATION

Model Number	100/179/060
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Information received a smiths medical intubation|portex endotracheal tubes nasal line became detached.Reported during the use of the product, the customer could not perform nasal intubation smoothly.For other reasons then listed but the report indicated the line was detached.No patient injury.
Additional Manufacturer Narrative
Investigation completed on a smiths medical intubation|portex endotracheal tubes inflation line detaches was confirmed.Sample returned: one (1) sample was returned for evaluation p/n 100/179/060.The sample was received in used conditions without original package.Results: inflation line detached was found.And a lack of solvent was observed, on tip of the inflation line.All mitigations on placed were verified, and it was confirmed has been executing according.Therefore, no corrective actions could be implemented.It will be continue monitoring this failure condition in this product, for threshold or escalation.
Event or Problem Description
Device analysis completed and summary in h10.
Additional Manufacturer Narrative
Updated type of malfunction to serious injury due to tracheostomy tube change out.

• Brand Name: PORTEX
• Common Device Name: NASAL INTUBATION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 11813979
• Report Number: 3012307300-2021-04273
• Device Sequence Number: 3148996
• Product Code: BTR
• UDI-Device Identifier: 15019315022104
• UDI-Public: 15019315022104
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2022

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: Health Professional
• Device Model Number: 100/179/060
• Device Catalogue Number: 100/179/060
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 08/01/2021; 08/01/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 08/30/2021; 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Race: Asian