MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN CLOSED SUCTION CATHETER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number UNKNOWN

Device Problem Disconnection (1171)

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

Event Date 12/29/2018

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 21-jan-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).Device not returned.

Event Description

It was reported that the suction tube disconnected from the suction port.No patient injury reported.

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.The device history record for lot m18150t505 was reviewed and the product was produced according to product specifications.All information reasonably known as of 19 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

One used sample was returned for evaluation.The catheter was received detached from the bushing.Under magnification, the severed end of the tubing appeared jagged, with possible kerf marks.The protective sleeve exhibited a v shaped cut in the material.The distal end of the bushing was viewed under magnification.The proximal end of the tubing remained connected to the bushing and was severed flush with the end of the bushing.The edge was jagged in appearance.The complaint was confirmed, and the root cause was determined to be use related.All information reasonably known as of 24 apr 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: UNKNOWN CLOSED SUCTION CATHETER
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8264170
• MDR Text Key: 134511509
• Report Number: 8030647-2019-00013
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/18/2019

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: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: M18150T505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 03/12/2019; 04/18/2019
• Supplement Dates FDA Received: 03/19/2019; 04/24/2019
• Patient Sequence Number: 1