MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION CATHETER, T-PIECE; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 2205

Device Problems Leak/Splash (1354); Pressure Problem (3012)

Patient Problem Respiratory Distress (2045)

Event Type  malfunction  

Manufacturer Narrative

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.All information reasonably known as of 22 jul 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

Medwatch user facility report number mw (b)(4) was received on 01-jul-2019 and the following information was provided: "the respiratory therapist (rt) installed the inline suction after the pt [patient] had been on the vent for a couple hours, before installing the rt was averaging good returned tidal volumes with minimal pt leak, around 0-1%.After installing the inline suction the returned tidal volumes decreased by almost half and there was about 70-75% pt leak.The sleeve that sits over the suction catheter was inflated (it's usually deflated) and the rt figured that this was most likely cause of the leak, so the rt removed the inline suction and the volumes returned to normal and there was minimal pt leak." original intended procedure was listed as "provide inline suction to ventilated patient." additional information has been requested but not yet provided.

Manufacturer Narrative

The actual complaint product was returned for evaluation.One used suction catheter with flex connector attached was received; no product packaging was received.No visible damage or excessive curvature was observed.Root cause could not be determined.A possible root cause based on sample analysis is use error.Instructions for the product usage can be reviewed in the ifu that is included in package.In caution section it is stated: "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." the device history record for lot m18171l616 was reviewed and the product was produced according to product specifications.All information reasonably known as of 17 sep 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, T-PIECE
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8813254
• MDR Text Key: 152096521
• Report Number: 8030647-2019-00070
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2023
• Device Model Number: 2205
• Device Catalogue Number: 991093906
• Device Lot Number: M18171L616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2019
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 74