MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) AVANOS BALLARD* CLOSED SUCTION CATHETER SYSTEM FOR NEONATES/PEDIATRICS; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Patient Problems Intracranial Hemorrhage (1891); Foreign Body In Patient (2687)

Event Date 06/23/2023

Event Type  Injury  

Event Description

Approximately 4cm of the 6 french avanos inline suction catheter tip was discovered to be an unintended 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.Lots: 30219596; 30179091.Routine x-ray on (b)(6) 2023 revealed "left lung mainstem linear tubular opacity concerning for foreign body with distal probable atelectatic changes of left lower lobe".Follow up ct demonstrated, "plastic foreign body extending from the distal trachea into the left lower lobe.Device may be within the medial basal segmental bronchus or in the lung parenchyma." while reviewing this case, and after reviewing seven case studies from 2010-2021 it is suggested that the manufacturer make the catheter radiopaque.On (b)(6) 2023, a 31+6 week estimated gestational age (ega) female infant was admitted to the neonatal intensive care unit (nicu) for prematurity and respiratory distress.On (b)(6) 2023, a routine chest x-ray demonstrated an unintentionally retained foreign object (urfo) in the lungs.The patient was transferred to an outside hospital for neurosurgical intervention for a grade 4 intraventricular hemorrhage (ivh).The urfo reportedly was removed during a bedside procedure without further complication.

• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.); alpharetta GA 30004
• MDR Report Key: 17691052
• MDR Text Key: 322973211
• Report Number: MW5145185
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 10 DA
• Patient Sex: Female
• Patient Weight: 144 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American