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

Model Number	2270135
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
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 14 sep 2020 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 21 different incidences, which were associated with separate units, involving 21 different patients.This is the eighteenth of twenty-one reports.Refer to 8030647-2020-00059 for the first report.Refer to 8030647-2020-00060 for the second report.Refer to 8030647-2020-00061 for the third report.Refer to 8030647-2020-00062 for the fourth report.Refer to 8030647-2020-00063 for the fifth report.Refer to 8030647-2020-00064 for the sixth report.Refer to 8030647-2020-00065 for the seventh report.Refer to 8030647-2020-00066 for the eighth report.Refer to 8030647-2020-00067 for the ninth report.Refer to 8030647-2020-00068 for the tenth report.Refer to 8030647-2020-00069 for the eleventh report.Refer to 8030647-2020-00070 for the twelfth report.Refer to 8030647-2020-00071 for the thirteenth report.Refer to 8030647-2020-00072 for the fourteenth report.Refer to 8030647-2020-00073 for the fifteenth report.Refer to 8030647-2020-00074 for the sixteenth report.Refer to 8030647-2020-00075 for the seventeenth report.Refer to 8030647-2020-00077 for the nineteenth report.Refer to 8030647-2020-00078 for the twentieth report.Refer to 8030647-2020-00079 for the twenty-first report.It was reported that the closed suction catheter was not staying attached to the patient's tracheotomy tube.The hospital started using an omni-flex adapter to improve the connection.Per additional information received on 08 sep 2020 , the product was in use for "hours" when the incident occurred.There was no harm to the patient.Per information received on 10 sep 2020, no further information is available.

• Brand Name: BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, T-PIECE
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10535415
• Report Number: 8030647-2020-00076
• Device Sequence Number: 12259725
• Product Code: BSY
• UDI-Device Identifier: 00609038947013
• UDI-Public: 00609038947013
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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: 2270135
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• 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: 08/28/2020
• Initial Report FDA Received Date: 09/15/2020
• 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