MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 60P055

Device Problem Structural Problem (2506)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

B3: date of event is unknown, no information has been provided to date.E2 - incorrect due to system limitations.Initial reporter is strategic purchasing and product manager.H3 - other: device has not been returned to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was stated that a "wire was coming out of both the one and the other cannula".The event date, lot number and patient involvement are unknown.No harm has been reported.The product will be available for investigation after the distributor will receive it.

Manufacturer Narrative

D9: date returned to mfg.: 3/11/2024.B5, d4, d5, h3, h4, h6.Health effects and evaluation codes: updated.Two device samples were received in used condition, in a plastic bag.During visual inspection it was identify a broken cuff, no exposed wire was identified in the samples.The failure mode of ¿guidewire problem¿ was not confirmed.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.No action was taken since the reported failure was not confirmed.

Event Description

Additional information was received via email clarifying that there are two products that need to be investigated.The event occurred after preparation with the vaporizer.The operator of the device was a care giver.There was patient involvement, and no patient harm/adverse event was reported.No medical intervention was required.The event date is unknown.No further information is available.

• Brand Name: BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 18530084
• MDR Text Key: 333464584
• Report Number: 9617604-2024-00058
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15021312005783
• UDI-Public: (01)15021312005783
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 60P055
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1