MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, ELBOW WITH CAPS; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	92431
Medical Device Problem Codes	Contamination (1120); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 12 apr 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.
Event or Problem Description
It was reported, a piece of the closed suction catheter (csc), came off "inside the suction" for a trach-patient, no injury was reported.Additional information received 21 mar2024 reported, the flapper valve of the csc which had been in place for 3 days, became detached and went into the patient's airway during suctioning, (when the parent withdrew the catheter from the child's airway, the flapper valve was noted to be on the tip of the catheter).The csc was replaced with a new one.The patient did not desaturate or have any other adverse effects; no further medical interventions were required, the patient remains at baseline.
Additional Manufacturer Narrative
A review of the device history record is in-progress.All information reasonably known as of 21 may 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.
Additional Manufacturer Narrative
Correction: d4.Additional information: d4; h6.The device history record for lot 30271857 was reviewed and the product was produced according to product specifications.A closed suction catheter sample was returned with an opened original pouch packaging in the lab for evaluation.During visual examination of the device, a light blue-ish foreign material was found taped to the product label; no other foreign material was seen or observed.The piece of matter/material was inspected under magnification (20x); it appeared to be hard and thin and measured 12mm long.During evaluation it was noted the material did not belong to the flapper valve, as described in the complaint description as this code does not include a flapper valve in its components; additionally, the piece of matter did not correspond to any of the components of the catheter.The reported event could be confirmed as reported; however, the root cause is undetermined as the origin of the piece of foreign material could not be traced to any of the assembly or packaging operations at the manufacturing plant.All information reasonably known as of 07 jan 2025 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: BALLARD CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, ELBOW WITH CAPS
• Common Device Name: 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: 19117847
• Report Number: 8030647-2024-00021
• Device Sequence Number: 18032067
• Product Code: BSY
• UDI-Device Identifier: 00609038924311
• UDI-Public: (01)00609038924311(10)30271857(11)230802(17)280723
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2025

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: Lay User/Patient
• Device Model Number: 92431
• Device Catalogue Number: 20083
• Device Lot Number: 30271857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 05/07/2024; 12/10/2024
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 05/23/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 MO
• Patient Sex: Female
• Patient Weight: 8 KG