MAUDE Adverse Event Report: AVANOS MEDICAL INC. TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 72-HOUR, 12 F, DSE; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 22716-4J

Device Problem Disconnection (1171)

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

Event Type  malfunction  

Manufacturer Narrative

The sample is reported to be available, but has not yet been received by the manufacturer.The device history record for the reported lot number, m7284t302 in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 19-feb-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 (b)(4).The device was not returned.

Event Description

Avanos medical, inc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different events.This is the first of two reports.Refer to 8030647-2019-00028 for the second event.It was reported connection between suction catheter and flex connector was loose and it came off during use.The suction catheter was replaced for a new device immediately.There was no patient injury.

Manufacturer Narrative

One used suction catheter and one used flex connector were received.The packaging label was also received.The male insert of the dse (double swivel elbow) was examined.There is no visible damage to the manifold or to the male insert.The device was evaluated and failure was confirmed.The root cause was manufacturing related.All information reasonably known as of 07-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: TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 72-HOUR, 12 F, DSE
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8354795
• MDR Text Key: 137686809
• Report Number: 8030647-2019-00026
• 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
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2022
• Device Model Number: 22716-4J
• Device Catalogue Number: 991099430
• Device Lot Number: M7284T302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 03/07/2019
• Patient Sequence Number: 1