MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	227-5
Medical Device Problem Codes	Increase in Suction (1604); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Decreased Peak Expiratory Flow rate (2435)
Date of Event	10/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was noted to have no expiratory flow while on the ventilator.Investigation found that the closed suction catheter was continually active.Per additional information received 8 nov 2021, a patient with severe asthma was on a ventilator with high pressures, when there was an alert due to no expiratory flow.The cause was found to be malfunction of suction catheter whereby the patients airway was subjected to continuous suction." the patient was deeply sedated and paralysed (where was unparalysed and less deeply sedated prior), the ventilator switched out and anaconda removed from circuit.A chest ultrasound was performed.A bronchoscopy was performed to check tube position.This was when the malfunctioned suction catheter was identified, as ventilation improved after the in line suction was removed from the circuit to switch in bronchoscopy angle piece.It was determined that the button on the closed suction was stuck in the depressed position, which made the tidal volume appear very low on the ventilator.
Additional Manufacturer Narrative
Clinical impact: bronchoscopy.The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.All information reasonably known as of 11 nov 2021 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.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).
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of (b)(6) 2021 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
Per additional information received 10 nov 2021, the catheter was replaced with a new one."the patient was ok once the catheter had been replaced.".
Additional Manufacturer Narrative
The device history record for lot 30061352 was reviewed and the product was produced according to product specifications.One used sample was returned for evaluation.Evaluation of the returned sample revealed that the reported event was potentially related to a previously identified manufacturing process.Improvements to the manufacturing process had already been identified and implemented.All information reasonably known as of 29 dec 2021 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 TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW
• 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12803904
• Report Number: 8030647-2021-00045
• Device Sequence Number: 14846716
• Product Code: BSY
• UDI-Device Identifier: 00609038924670
• UDI-Public: 00609038924670
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/29/2021

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: Health Professional
• Device Expiration Date: 04/30/2025
• Device Model Number: 227-5
• Device Catalogue Number: N/A
• Device Lot Number: 30061352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• 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: 10/28/2021
• Supplement Date Received by Manufacturer: 11/10/2021; 12/22/2021
• Initial Report FDA Received Date: 11/12/2021
• Supplement Report FDA Received Date: 12/01/2021; 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2020
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANACONDA
• Outcome Attributed to Adverse Event: Other
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 50 KG