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

Model Number	2210-5
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, there was a large discrepancy between set ventilation (vt) and exhaled vt (450 ml vs.200 ml).The inline suction was changed and the volume loss resolved and the set vt was equal to exhaled vt.There was no reported injury.Additional information received 30aug2023 reported, the adult patient displayed a large leak with ventilator volumes set at 450mls and measured back at 280-350mls.The patient was upsized to an 8.0 breathing tube; however, a leak was still noticed.The respiratory [therapist] (rt) closed the suction catheter and a new inline suction catheter was placed and the leak disappeared completely.It was additionally reported, due to the leak the team had to: increase the ventilator settings to compensate for poor gas exchange; extra manipulation of the patient¿s airways was required due to the exchange of the endotracheal tube (ett); and extra paralytic/sedation was given for the procedure.It was also noted that on-going blood was being suctioned from the patient¿s lungs.There was no reported injury to the patient.
Additional Manufacturer Narrative
H6: 4650-appropriate health impact/code not available: on-going blood was being suctioned from the patient¿s lungs.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 14 sep 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.
Additional Manufacturer Narrative
The device history record for lot 30109742 was reviewed and the product was produced according to product specifications.The returned product was evaluated and no issues were observed on device.The root cause could not be determined since the reported failure was not reproduced in lab during sample evaluation.All information reasonably known as of 14 nov 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.
Additional Manufacturer Narrative
Correction: e1.Additional information: d9; h3; h6.All information reasonably known as of 05 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.

• Brand Name: BALLARD 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: 17765920
• Report Number: 8030647-2023-00113
• Device Sequence Number: 6976983
• Product Code: BSY
• UDI-Device Identifier: 00609038983103
• UDI-Public: 00609038983103
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2025
• Device Model Number: 2210-5
• Device Lot Number: 30109742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 10/04/2023; 11/13/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/05/2023; 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2020
• 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
• Patient Sex: Unknown