MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC SILICONE - BIVONA TUBES CUSTOM TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FU19AN30NGC082N
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Irritation (1941); Discomfort (2330)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation results: one bivona custom tracheostomy was returned for investigation.The returned device was compared to a template device.The returned device was made with a 4 c neck flange, which is an adult straight neck flange (83 mm).The neck flange type selected by the clinician was the 4c neck flange.The ordering history for the part number revealed that there has only been one lot produced for the lot number.A query of the patient's name in the custom lab database did not reveal any other customized part numbers which were ordered.Based on the template's specifications (3.0 mm id, 25 mm proximal length and 39 mm distal length), and the information provided in the complaint description, it is hypothesized that the complainant previously used a standard / stock product, 60pfs30.The standard product is built with a v-shaped neck flange and has a 3.0 mm id, 20 mm proximal length and 39 distal length.If the complainant wanted the v-shaped neck flange on a shaft that was built with a 25 mm proximal length and 39 distal length, a new template should have been provided by the clinician.The clinician originally identified a 4a neck flange.
Event or Problem Description
It was reported that the trach was worn out and caused the patient to feel some irritation and discomfort.This occurred four days after the placement of the trach.The issue was caused by a flange which extended in straight direction, like a bar.The flange had previously been shaped like the letter v.The trach pressed against the patient's trach site.The customer believed that the big circle disk is what was pressing against the trach site.The patient's mother switched the patient to another trach tube and observed the same issue.The mother subsequently switched back to the first trach tube discussed above.The patient issue reported above was resolved after the switch was made to the original trach tube.No further patient complications were reported in connection with this event.
Additional Manufacturer Narrative
One tracheostomy was returned for evaluation.Device was made with the 4c neck flange, an adult straight neck flange (83 mm ).The neck flange type selected by the clinician was the 4c neck flange.The ordering history for part number fu19an30ngc082n revealed that there has only been one lot produced.A query of the patient's name in the custom lab database did not reveal any other customized part numbers.Based on the template's specifications (3.0 mm id, 25 mm proximal length and 39 mm distal length) and the information provided in the complaint description, it is hypothesized that the complainant previously used a standard / stock product, 60pfs30.The standard product is built with a v-shaped neck flange and has a 3.0 mm id, 20 mm proximal length and 39 distal length.If the customer wants the v-shaped neck flange on a shaft that is built with a 25 mm proximal length and 39 distal length, a new template will need to be provided by the clinician identifying the 4a neck flange.No corrective actions are planned at this time.

• Brand Name: SILICONE - BIVONA TUBES CUSTOM 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: 8574933
• Report Number: 3012307300-2019-35278
• Device Sequence Number: 254651
• Product Code: JOH
• UDI-Device Identifier: 15019517178425
• UDI-Public: 15019517178425
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 150195171784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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?: Yes
• Operator of Device: No Information
• Device Model Number: FU19AN30NGC082N
• Device Catalogue Number: FU19AN30NGC082N
• Device Lot Number: DS023930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1