MAUDE Adverse Event Report: BALLARD MAP ADULT, 14 FR, DSY, MDI; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	240148-5
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A review of the device history record is in-progress.The actual complaint product was not returned for evaluation.A photo of the device was provided by the customer.All information reasonably known as of 19 nov 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 inc.Complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that a crack caused the system to snap in half, causing immediate loss of volume to the patient.The system was replaced.Additional information received 05-nov-2020 indicated, "endotracheal aspiration required in covid19 patient, by turning the double pivot elbow to align the suction tube with the intubation tube, the elbow broke in half." apart from changing the closed system, no medical intervention was necessary.
Additional Manufacturer Narrative
Per review it was determined that the original lot number reported was not a valid avanos lot number.A review of the device history record is not possible as a valid lot number was not provided.A photo of the device was provided by the customer; however, no root cause could be determined.All information reasonably known as of 18 dec 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 inc.Complaint database and identified as complaint (b)(4).

• Brand Name: BALLARD MAP ADULT, 14 FR, DSY, MDI
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10880297
• Report Number: 8030647-2020-00090
• Device Sequence Number: 19784098
• Product Code: BSY
• UDI-Device Identifier: 00609038200705
• UDI-Public: 00609038200705
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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 Model Number: 240148-5
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/18/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other