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

Model Number	35W055
Medical Device Problem Codes	Crack (1135); Fracture (1260); Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign: (b)(6).Device evaluation: two aire-cuf devices were returned for evaluation.Visual inspection of the devices found them to be crimped and deformed.The crimp marks on device a were located 100 mm and 135 mm from the underside of the connector.The crimp marks on device b were located 115 mm and 160 mm from the underside of the connector.The "crack" on device a was located 103 mm from the underside of the connector.The "crack" on device b was located 117 mm from the underside of the connector.Both "cracks" were located in between the two crimp marks.Using magnification, the "cracks" were identified as cut marks, likely caused by whatever crimped the devices.The cuff on device a was unable to be inflated.Device a was leaked tested; it leaked at the location of the "crack" due to the cut being position across the embedded lumen in the shaft.The cuff on device b was able to be inflated and remained inflated until the device was manually deflated by releasing the inflation valve.Device b was leaked tested; no leaks were detected.The cut on device b was not position across the embedded lumen in the shaft so it did not affect the inflation/deflation of the cuff.Additionally, the lot was 200% inspected (once by manufacturing and once by quality) for cosmetic and function criteria.These inspections would have identified a deformity in the shaft and an inflation/deflation fault.The investigation did not determine a manufacturing fault with the returned device.Based on the investigation, the complaint allegation was confirmed, where devices were found to be damaged, but only one device did not inflate.The event problem source was noted to be user interface.
Event or Problem Description
Information was received that a smiths medical portex bivona small diameter aire-cuf wire reinforced endotracheal tube was crimped and deformed.No adverse effects were reported.
Event or Problem Description
Information was received stating device was not used on a patient due to the crack in the line.

• Brand Name: PORTEX BIVONA SMALL DIAMETER AIRE-CUF WIRE REINFORCED ENDOTRACHEAL TUBE
• 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: 8865649
• Report Number: 3012307300-2019-04022
• Device Sequence Number: 2070562
• Product Code: BTR
• UDI-Device Identifier: 15021312014334
• UDI-Public: 15021312014334
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K792035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: No Information
• Device Expiration Date: 10/16/2022
• Device Model Number: 35W055
• Device Catalogue Number: 35W055
• Device Lot Number: 3491380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1