MAUDE Adverse Event Report: BALLARD CLOSED SUCTION SYSTEM FOR ADULTS WITH BALLARD TECHNOLOGY; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	2210-5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided.The device history record for the reported lot number, 30014141, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 30-jul-2020 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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, "the inner swivel of the closed suction broke off from the airway connector." there was no reported injury.Additionally, the users noted the inline suction catheter broke in multiple places when trying to disconnect the suction tubing.The tapered plastic adapter completely disconnected from the end of the device.Furthermore, when removing a pink saline ampule from the side port the entire interior portion pulled out and the tubing had to be clamped to stop the continuous leak.
Additional Manufacturer Narrative
Correction: d4.A photograph of the device was provided and confirmed the reported incident.A root cause was not identified.All information reasonably known as of 07-oct-2020 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.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: BALLARD CLOSED SUCTION SYSTEM FOR ADULTS WITH BALLARD TECHNOLOGY
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10349820
• Report Number: 8030647-2020-00052
• Device Sequence Number: 11437320
• Product Code: BSY
• UDI-Device Identifier: 00609038983103
• UDI-Public: 00609038983103
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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 Expiration Date: 11/30/2024
• Device Model Number: 2210-5
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 30014141
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 07/31/2020
• Supplement Report FDA Received Date: 10/08/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1