MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA

Model Number	ZT20FN60NSB061N
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Itching Sensation (1943)
Date of Event	07/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a smiths medical custom tracheostomy tube was placed and a day after, the patient complained of several itching spots near the stoma.The parents noted that the area around the stoma was red.After one more day, the child was unable to handle the pain any more and the trach had to be changed.Parents noted that there was bleeding around the stoma.The trach was replaced with a stock trach and within 20 minutes, the itching and discomfort subsided and the patient continued to heal with no further complications.
Additional Manufacturer Narrative
Other, other text: evaluation results: one custom bivona tracheostomy tube was returned for investigation in used condition.Visual inspection did not reveal any anomalies with the device.Review of the dhr for the custom device confirmed that the device was made to the template.Per review of the device database, the returned device was the first device ordered for the end user.Since no lot number was provided for the standard product, a dhr review was unable to be performed.There are several differences between the custom device and the standard product, which could have contributed to the irritation experienced by the end user.1.The custom device was ordered non-sterile and the standard product is purchased sterile.Whatever method or solution used to clean the custom device may have contributed to the irritation the end user experienced.2.The custom shaft is manufactured using a silicone gumstock and the standard shaft is manufactured using a silicone liquid rubber.The end user may have sensitivity to the silicone used to manufacture the custom device.3.The custom device has an opaque, white stripe on the device, which contains barium sulfate.The standard product does not contain a barium sulfate stripe.The end user may have a sensitivity to barium sulfate, which contributed to the end user's sensitivity.4.All standard products have a parylene coating applied to the silicone features (excludes plastic components e.G., connector); custom devices do not have the parylene coating applied to the silicone.The end user may be sensitive to silicone and the parylene coating provides a barrier.5.The connector profile and the eyelet profiles on the custom device are larger than the standard product.Depending on the end users physical attributes, the bulkiness of the custom device may have contributed to rubbing underneath the chin or on the stoma area causing irritation.The investigation did not identify a manufacturing defect with the returned device.The root cause for irritation was unable to be identified - only possible hypothesis for the complainant to follow up with the physician.

• Brand Name: BIVONA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10455093
• Report Number: 3012307300-2020-08498
• Device Sequence Number: 3032756
• Product Code: JOH
• UDI-Device Identifier: 15019517232387
• UDI-Public: 15019517232387
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2020

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: Lay User/Patient
• Device Model Number: ZT20FN60NSB061N
• Device Lot Number: BS008086
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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: Required Intervention