MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 195-4J

Device Problem Break (1069)

Patient Problems Stenosis (2263); Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.The device history record for lot m18323t403 was reviewed and the product was produced according to product specifications.All information reasonably known as of 21 jun 2019 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 halyard health complaint database and identified as complaint (b)(4).

Event Description

Avanos medical inc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 8030647-2019-00060 for the second report.Refer to 8030647-2019-00061 for the third report.It was reported that "a suction catheter came off the thumb valve and it fell into the endotracheal tube during suctioning.A patient had the tracheal stenosis and oxygen desaturation.The value dropped down to 82%.The suction catheter was removed from the endotracheal tube, but it was difficult to collect it and took time.The suction catheter was replaced for new one immediately." additional information received on 05-jun-2019 indicated that "the patient recovered from oxygen desaturation soon and there is no problem with the patient's condition now.The size of the endotracheal tube is 2.5mm.".

Manufacturer Narrative

One used sample was returned for evaluation.The sample was received with the bushing detached from the cone adapter.The catheter tubing remained attached to the bushing.The components were viewed under uv light and there was little to no evidence of adhesive found.The complaint is confirmed as reported.The root cause was determined to be manufacturing related.All information reasonably known as of 13 aug 2019 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 CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8726774
• MDR Text Key: 148977723
• Report Number: 8030647-2019-00059
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/13/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2023
• Device Model Number: 195-4J
• Device Catalogue Number: 991099312
• Device Lot Number: M18323T403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2019
• Initial Date FDA Received: 06/24/2019
• Supplement Dates Manufacturer Received: 08/08/2019
• Supplement Dates FDA Received: 08/13/2019
• Patient Sequence Number: 1