MAUDE Adverse Event Report: BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	2271418-5
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is not possible as no lot number was provided.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 08 dec 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Complaint database and identified as complaint (b)(4).
Event or Problem Description
Avanos medical inc.Received a single report that referenced ten different incidences, which were associated with separate units, involving different patients.This is the seventh of ten reports.Refer to 8030647-2020-00104 for the first report.Refer to 8030647-2020-00105 for the second report.Refer to 8030647-2020-00106 for the third report.Refer to 8030647-2020-00107 for the fourth report.Refer to 8030647-2020-00108 for the fifth report.Refer to 8030647-2020-00109 for the sixth report.Refer to 8030647-2020-00111 for the eighth report.Refer to 8030647-2020-00112 for the ninth report.Refer to 8030647-2020-00113 for the tenth report.It was reported that the flex tube [flex connector] disconnected from the closed suction system.Product was in use for one to three days.No patient injury was reported.

• Brand Name: BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10971092
• Report Number: 8030647-2020-00110
• Device Sequence Number: 16334986
• Product Code: BSY
• UDI-Device Identifier: 00609038982632
• UDI-Public: 00609038982632
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: 2271418-5
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/08/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1