MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEMS FOR NEONATES/PEDIATRICS, Y-ADAPTER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 198

Device Problems Break (1069); Gas/Air Leak (2946); Material Integrity Problem (2978)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2023

Event Type  Injury  

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 second of two reports.Refer to 8030647-2023-00099 for the first report.It was reported, that on (b)(6) 2023, the plastic sheath covering the suction catheter was found split open at the seam which left the patients vent circuit open causing a leak on the vent and the patient to desaturate and contaminated the suction catheter.No injury reported to patient.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress all information reasonably known as of 30 jun 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.

Manufacturer Narrative

All information reasonably known as of 27 jul 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.

Event Description

It was reported, the staff switched out to a new catheter, there was no reported injury.

Manufacturer Narrative

Correction: g4.The device history record for lot 30212926 was reviewed and the product was produced according to product specifications.The root cause could not be determined.All information reasonably known as of 06 dec 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 comp(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, Y-ADAPTER
• 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 17252560
• MDR Text Key: 318451128
• Report Number: 8030647-2023-00100
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 00609038938264
• UDI-Public: 00609038938264
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 198
• Device Lot Number: 30212926
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2022
• 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
• Patient Age: 2 MO
• Patient Sex: Male