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

Model Number	240168-5
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Suction Failure (4039)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	02/11/2022
Type of Reportable Event	Serious Injury
Additional 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 28 feb 2022 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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
Avanos medical inc.Received a single report that referenced at least three different incidences, which were associated with separate units, involving different patients.This is the first of three reports.Refer to 8030647-2022-00072 for the second report; refer to 8030647-2022-00073 for the third report.It was reported that there was breathing distress of the intubated patient.It was determined that the closed system catheter (csc) was blocked and could not suction, due to the suction probe becoming "stuck" inside the multi-access port manifold.The patient is covid-positive and the carer had to disconnect the system and used a "conventional probe" to perform suction.No further information is available.

• Brand Name: BALLARD MULTI-ACCESS PORT (MAP) CATHETER, DOUBLE SWIVEL Y
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp 84160 ; MX 84160
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13651768
• Report Number: 8030647-2022-00071
• Device Sequence Number: 14045821
• Product Code: BSY
• UDI-Device Identifier: 00609038200729
• UDI-Public: 00609038200729
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

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 Model Number: 240168-5
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown