MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) 6 FRENCH AVANOS INLINE SUCTION CATHETER TIP; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Lot Number 30219596

Patient Problem Foreign Body In Patient (2687)

Event Date 10/02/2023

Event Type  Injury  

Event Description

Approximately 4cm of the 6 french avanos inline suction catheter tip was discovered to be a retained foreign object within the lung of an intubated neonate patient.It is unknown as to whether or not the catheter tip was inadvertently severed or if the catheter tore during use.Lot number of specific device is unknown as two different lot numbers were stocked at the time of discovery.Reference report #mw5150576.

• Brand Name: 6 FRENCH AVANOS INLINE SUCTION CATHETER TIP
• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 18551848
• MDR Text Key: 333474328
• Report Number: MW5150575
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• 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: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 30219596
• Patient Sequence Number: 1