MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMALL DIAMETER AIRE-CUF WIRE REINFORCED ENDOTRACHEAL TUBE (SILICONE); TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	35W070
Medical Device Problem Codes	Inflation Problem (1310); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Airway Obstruction (1699); Hypoxia (1918); Swelling (2091)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received that a smiths medical portex bivona small diameter aire-cuff wire reinforced endotracheal tube (silicone) was in use with a patient for delivery of anesthesia.The reporter stated the device was in use for 15 minutes when the user noted the patient's throat area was swollen and was observed to have "life threatening" hypoxia.Subsequently, the tube was removed and the inflation cuff was found to only be partially inflated (not symmetrical).The reporter also stated the cuff may have been pressing against the tracheal posterior wall.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Evaluation results: three portex endotracheal tubes were returned for investigation.One of the devices was used and the other two were unused and in their original packaging.An inflation test was performed on the cuff of the used endotracheal tube.The cuff was inflated with 20 cc of air using a standard syringe.The cuff was then measured with a standard ruler from the center of the cuff to the smaller side of the cuff.The length was measured at 7 mm.The cuff was then measured from the center of the cuff, to the larger side of the cuff.This length was 22 mm.Based on these measurements, it was determined that the device did not meet manufacturing specification.The two other unused endotracheal tubes did meet manufacturing specification after similar measurements were taken.

• Brand Name: SMALL DIAMETER AIRE-CUF WIRE REINFORCED ENDOTRACHEAL TUBE (SILICONE)
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8557480
• Report Number: 3012307300-2019-02183
• Device Sequence Number: 2309098
• Product Code: BTR
• UDI-Device Identifier: 15021312014365
• UDI-Public: 15021312014365
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K792035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 03/07/2023
• Device Model Number: 35W070
• Device Catalogue Number: 35W070
• Device Lot Number: 3572778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention