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

Model Number	197
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Bacterial Infection (1735); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information received 19jan2023 reported, mid-shift on (b)(6) 2023, the registered nurse (rn) found the plastic sleeve to the closed suction catheter (csc) ¿open nearly end to end¿.They were unsure if it had been that way before as the tear was only visible on one side; the patient had been suctioned at least hourly for most of the day; the csc had been in use for possibly 5 days.The patient was evaluated for sepsis, a trach aspirate (ta) was performed and found to have gram positive cocci for which the infant was started on antibiotics.A chest x-ray (cxr) revealed areas of atelectasis that may or may not have been associated with a pneumonia; a peripheral blood culture was positive for enterococcus fecalis, (considered an absolute pathogen); arterial blood was negative for any microbes.It was additionally reported, there was no way to definitively associate potential central line-associated bloodstream infection (clabsi) with (ta) except same grams stained description for organism.Additional information received 06feb2023 clarified, the ta was negative, performed on (b)(6) 2023; the blood culture was positive.
Additional Manufacturer Narrative
4581-appropriate clinical signs, symptoms, conditions term/code not available: atelectasis.The sample is reported to be available but has not yet been received by the manufacturer.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 14 feb 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.Device not returned.
Additional Manufacturer Narrative
All information reasonably known as of 07 mar 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
Additional information: d4 the actual sample from the reported event was returned for evaluation.Visual examination of the device revealed the tearing on the sleeve started from the peep seal location.The reported event could be confirmed as reported; however, the root cause is undetermined.The device history record for lot 30202148 was reviewed and the product was produced according to product specifications.All information reasonably known as of 02 apr 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 SYSTEMS FOR NEONATES/PEDIATRICS, Y-ADAPTER
• 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: 16375824
• Report Number: 8030647-2023-00024
• Device Sequence Number: 17573192
• Product Code: BSY
• UDI-Device Identifier: 00609038938257
• UDI-Public: 00609038938257
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2023

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 Model Number: 197
• Device Lot Number: 30202148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 02/16/2023; 03/08/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/08/2023; 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED ANTIBIOTIC
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Other
• Patient Age: 12 DA
• Patient Sex: Female
• Patient Weight: 2 KG