MAUDE Adverse Event Report: AVANOS MEDICAL INC. CLOSED SUCTION SYSTEM FOR NEONATES / PEDIATRICS, 5 F, Y-ADAPTER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 198-5

Device Problem Inflation Problem (1310)

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

Event Date 11/09/2018

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.The device history record for the reported lot number, m18135t501, 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 18-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).

Event Description

It was reported the, "plastic sleeve was filled with air when suction was performed at the second time of use." there was no reported injury.No additional information was provided.

Manufacturer Narrative

One used suction catheter was received along with three y-adapters (3.0, 3.5 and 4.0).The product packaging was received.The sample was examined under ambient light conditions.The catheter tubing exhibited significant set curvature.The device was evaluated and the failure was confirmed.The root cause was manufacturing related, root cause identified is that there was an operator and inspection error.All information reasonably known as of 26-feb-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.

Manufacturer Narrative

The investigation was updated.The complaint review results and the sample evaluation indicated there was no evidence that the device failure was due to the manufacturing process.The root cause was not identified.All information reasonably known as of 17-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 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, 5 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: 8264057
• MDR Text Key: 134511597
• Report Number: 8030647-2019-00005
• 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,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2019

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: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: 198-5
• Device Catalogue Number: 991098386
• Device Lot Number: M18135T501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/02/2019
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 02/26/2019; 04/02/2019
• Supplement Dates FDA Received: 03/22/2019; 04/18/2019
• Patient Sequence Number: 1