MAUDE Adverse Event Report: AVANOS MEDICAL INC. CLOSED SUCTION SYSTEM FOR NEONATES / PEDIATRICS, 7 F, Y-ADAPTER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 197-5

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record for the reported lot number, m7235t501, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.All information reasonably known as of 30-jan-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 avanos medical inc complaint database and identified as complaint (b)(4).

Event Description

It was reported that an in line suction catheter was connected soon after a patient was admitted to the pediatric intensive care unit.A leak was detected on the ventilator and was also audible near the patient's mouth.The equipment was checked and there was no obvious leak.Ultimately, it was presumed to be from the endotracheal tube.The leak began to hinder ventilation with poor breathing sounds from the patient and unreliable endotracheal carbon dioxide.The patient was put on an anaesthetic circuit and "hand bagged" while the equipment was checked again.It was noted that the patient did not have a leak when being hand bagged.The in line suction catheter was exchanged for a new one which resolved the leak.Additionally, it was noted the ventilation improved.

Manufacturer Narrative

One used sample was returned for evaluation.Visual examination revealed no damage to the device.The sample was tested for leaks and passed with no leaks observed.The sample catheter was then over-retracted, and tested again.The sample failed the leak test.The complaint cannot be confirmed when the sample was used as instructed.The only way to replicate the failure was to malposition the catheter.The potential root cause is incorrect use of a component by the user.Per the instructions for use: "stop withdrawal when black mark on the tip of the catheter is visible within the dome (fig.2).Withdrawal of the black mark past the dome, may inflate the protective sleeve of the suction catheter and may cause oxygen desaturation." all information reasonably known as of 22 mar 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.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 04-mar-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 inc 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: CLOSED SUCTION SYSTEM FOR NEONATES / PEDIATRICS, 7 F, Y-ADAPTER
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8296114
• MDR Text Key: 134737458
• Report Number: 8030647-2019-00017
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2022
• Device Model Number: 197-5
• Device Catalogue Number: 109838502
• Device Lot Number: M7235T501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2019
• Patient Sequence Number: 1
• Patient Age: 9 YR
• Patient Weight: 17