MAUDE Adverse Event Report: BALLARD MULTI-ACCESS PORT (MAP) CATHETER, DOUBLE SWIVEL Y, WET PAK; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	240166-5
Medical Device Problem Codes	Disconnection (1171); Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Hypoxia (1918); Respiratory Distress (2045)
Date of Event	04/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 20022821 was reviewed and the product was produced according to product specifications.All information reasonably known as of 05 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 or Problem Description
It was reported that the hospital has had a problem with disconnection of the closed suction catheter.This resulted in cardiorespiratory arrest on hypoxia, deterioration respiratory state, prolongation of hospitalization in intensive care.Per additional information received 17 jul 2020, the patient experienced hypoxia and cardiac arrest and was treated with 2mg adrenalin, fio2 at 100%, curarization and sedation.The patient required two more weeks in the intensive care unit.Per additional information received 20 jul 2020, the hospital reports that the instructions provided with the device are difficult to understand and user training will be performed.Per additional information received 22 jul 2020, the doctor reports that he found the endotracheal tube disconnected from the multi-access port close suction system.After the incident, the actions taken by the hospital were reported as "formations and icu nurses for supervision." the suction catheter had been attached to a 4 med serres bag with tubing.

• Brand Name: BALLARD MULTI-ACCESS PORT (MAP) CATHETER, DOUBLE SWIVEL Y, WET PAK
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10374674
• Report Number: 9611594-2020-00141
• Device Sequence Number: 11401248
• Product Code: BSY
• UDI-Device Identifier: 20609038101396
• UDI-Public: 20609038101396
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 240166-5
• Device Catalogue Number: N/A
• Device Lot Number: 20022821
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/06/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 87