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

Model Number	60SP030
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that one week following placement of a smiths medical portex bivona tracheostomy tube, a tear to the hub was found.It was reported that proper cleaning procedures were followed, and no external attachments had been used.The patient was reported to not be in distress, so no trach tube change out was required.There were no reported adverse effects.
Event or Problem Description
3/3 reference cc-0073132 for all attachments and related complaints.Damage to the hub was found after one week of use.Caregiver states that proper cleaning procedures are followed and no external attachments are being used.Pictures attached.Additional information received 01 june 2020 by phone call: the two devices that were sent in also had the same issue as above.The tear was found in the same place in all three trachs.The patient's mother did not do trach changes stating that the patient was not in distress.Normal trach changes were done when the patient was due for her trach changes.Investigation completed and in h 1-.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10200321
• Report Number: 3012307300-2020-06267
• Device Sequence Number: 1071853
• Product Code: JOH
• UDI-Device Identifier: 15021312000368
• UDI-Public: 15021312000368
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K912469
• 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): 08/25/2020

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: 09/05/2024
• Device Model Number: 60SP030
• Device Catalogue Number: 60SP030
• Device Lot Number: 3877643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/26/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR