MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN, VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number UNKNOWN

Device Problem Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

4581: appropriate clinical signs, symptoms, conditions term/code not available: left lung mainstem linear tubular opacity.4581: appropriate clinical signs, symptoms, conditions term/code not available: concerning for foreign body with distal probable atelectatic changes of left lower lobe.The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined all information reasonably known as of 06 oct 2023 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.H3 other text: device not returned.

Event Description

Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 8030647-2023-00117 for the second report.It was reported via fda medwatch/fda user facility report mw report mw5145185 the following information was provided: "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.".

Manufacturer Narrative

Clarification: while the lot number for the device alleged in this report remains unknown, the customer provided a lot number for the devices that were stocked at the time of the reported event.The dhr; catalog number; model/version and udi(s), which are provided below, are based on the customer stocked lots at the time of the event.The device history record for lot 30219596 was reviewed and the product was produced according to product specifications.Catalog number: 196 version/model: 93824 udi/additional udi: (b)(4).All information reasonably known as of (b)(6) 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

• Brand Name: UNKNOWN, VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp
• Manufacturer Contact: ujjal chakravartty ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485487
• MDR Report Key: 17914350
• MDR Text Key: 325413892
• Report Number: 8030647-2023-00116
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/27/2024

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?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 07/29/2024
• Supplement Dates FDA Received: 08/27/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other