MAUDE Adverse Event Report: BALLARD CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	22103-5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, "the inside piece of plastic (that attaches to the trach) came unattached from the outer plastic piece (that swivels).The inner portion was stuck on the patient's trach, and took some effort to get it off." there was not reported injury.Additional information received 13-oct-2021 states the device was in place for less than a week.The device was not altered from its original form.Respiratory therapy extracted the broken piece from the bivona tts trach tube.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 29-oct-2021 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, inc.Complaint database and identified as complaint (b)(4).

• Brand Name: BALLARD CLOSED SUCTION SYSTEM FOR ADULTS, 14 F, DSE
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 12725035
• Report Number: 8030647-2021-00044
• Device Sequence Number: 14449053
• Product Code: BSY
• UDI-Device Identifier: 00609038983110
• UDI-Public: 00609038983110
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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: 22103-5
• 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: 10/05/2021
• Initial Report FDA Received Date: 10/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BIVONA TTS TRACH TUBE
• Patient Age: 82 YR