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

Model Number 196-5

Device Problem Pressure Problem (3012)

Patient Problem Apnea (1720)

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record for lot m18316r501 was reviewed and the product was produced according to product specifications.Root cause could not be determined.All information reasonably known as of 06 may 2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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

It was reported "the respirator indicates 'apnea' while the child is breathing properly following the cycles of the respirator.There is 100% leakage.So i [complainant] check the circuit of my pipes, then i calibrate with a lung.There are no leaks with the lung, no leaks noted either when the trachcare is removed.Change of trachcare performed, no more leaks after the change.The respirator no longer sounds apnea either.".

Manufacturer Narrative

The actual complaint product was returned for evaluation.One used suction catheter with 2.5mm y-adapter attached was received; no product packaging was received.No damage was observed.The reported failure was not reproduced.Root cause could not be determined.All information reasonably known as of 17 jul 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).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: 8583855
• MDR Text Key: 146681036
• Report Number: 8030647-2019-00049
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2023
• Device Model Number: 196-5
• Device Catalogue Number: 991098384
• Device Lot Number: M18316T501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2019
• Patient Sequence Number: 1