MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67SP035
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a broken "wing" was discovered on a tracheal cannula on a child.The tracheal cannula was changed urgently during the evening\night shift by the ent department.The tracheal cannula was discarded.The tracheal cannula was last changed on 27-dec-2023.The parents stated that it was almost completely off.A crack at the "wing", near the "chimney", same side as the cuff.The customer reported that "there is no risk that we damaged the wing with scissors.After the incident, the circumference of the neckband was increased by 0.5 cm initially and then by an additional 0.5 cm, totaling 1 cm, to reduce tension on the wings.The neckband was then tied tightly so that the cannula cannot be pulled out.¿ risk of major injury if the wing broke, no free airway.There was no patient harm/adverse event reported.A possible lot number of 4348433 was provided.
Additional Manufacturer Narrative
Operator of device is unknown, no information has been provided to date.E1 reporter phone: (b)(6).Other; device not returned to manufacturer.D4: lot number, expiration date, h4: device manufacture date is unknown, as the provided lot number (4348433) cannot be confirmed by the customer.Device evaluation: no product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was not confirmed.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18808899
• Report Number: 9617604-2024-00192
• Device Sequence Number: 7169032
• Product Code: JOH
• UDI-Device Identifier: 15021312000719
• UDI-Public: 15021312000719
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/29/2024

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: Other
• Device Catalogue Number: 67SP035
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown