MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA CUSTOM 4.5 U/C FLEXTEND TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	ZU19BN45NGF065S
Medical Device Problem Codes	Break (1069); Material Separation (1562); Material Integrity Problem (2978); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical portex bivona custom 4.5 u/c flextend tracheostomy tube was in use with a patient at their home.The patient's mother was preparing a planned tube change for the indwelling device and noticed the "plastic piece inside the 15mm iso was shaving off and missing some chunks of plastic".The same issue was noticed on the replacement tube as it was checked prior to placement.There were no adverse patient effects.
Additional Manufacturer Narrative
Two devices were returned for evaluation.Visual inspection found the connector was shaved off- missing chunks of plastic.Visual inspection using a magnified lighted lamp revealed that the inside of the connector had abrasion marks.The abrasion marks were the result of a dremel device being used inside the connector either to remove excessive adhesive that had migrated inside the connector when attaching the shaft or to reduce the portion of the shaft that may have extended past the inside opening of the connector.The rough surface of the inside of the connector was deemed not to affect fit, form, or function of the device.The reported customer complaint has not been confirmed, as this process is common and necessary for devices built in the custom lab.

• Brand Name: PORTEX BIVONA CUSTOM 4.5 U/C FLEXTEND TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9638737
• Report Number: 3012307300-2020-00637
• Device Sequence Number: 2791396
• Product Code: JOH
• UDI-Device Identifier: 15019517190380
• UDI-Public: 15019517190380
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: Lay User/Patient
• Device Expiration Date: 08/12/2024
• Device Model Number: ZU19BN45NGF065S
• Device Catalogue Number: ZU19BN45NGF065S
• Device Lot Number: DS030674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 6 YR