MAUDE Adverse Event Report: UNKNOWN SUCTION CATHETER; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number UNKNOWN

Device Problem Material Fragmentation (1261)

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

Event Date 07/18/2020

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 17 aug 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 complaint database and identified as complaint (b)(4).

Event Description

It was reported that a foreign fragment was found in the catheter.Once removed it is determined to be a small piece of plastic.The tube was inspected and additional plastic pieces were noted in the suction catheter.The closed suction device was removed from the patient.It was reported that "at the top of the tracheal tube broken off pieces of plastic sitting lightly glued to the inside of the tracheal.The child side-mounted and the tube facing downwards to prevent the pieces fall into the tracheal tube, and the stumps pry out with a needle two of the smallest pieces however, falls further down the tube and one is attached on the tracheal tube to prevent the pieces falls into the patient." additional information was requested, however, hospital was unable to provide any further details.

Manufacturer Narrative

A photo of the device was provided by the customer, however, no root cause could be determined.All information reasonably known as of 20 oct 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 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 SUCTION CATHETER
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10417938
• MDR Text Key: 203486743
• Report Number: 9611594-2020-00155
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1