MAUDE Adverse Event Report: BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 198-5

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

The device history record for lot m18282t504 was reviewed and the product was produced according to product specifications.All information reasonably known as of 16 jun 2020 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.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 "y-adapter broke off because of which the ventilation tube came off." no patient injury was reported.Images of the device were provided.Additional information was requested but not yet received.

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A photo of the device was provided and the reported incident was confirmed.However, a root cause could not be determined.All information reasonably known as of 28 jul 2020 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: BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10174793
• MDR Text Key: 196789240
• Report Number: 8030647-2020-00035
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 00609038983868
• UDI-Public: 00609038983868
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

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: 10/17/2023
• Device Model Number: 198-5
• Device Catalogue Number: 109838601
• Device Lot Number: M18282T504
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1