MAUDE Adverse Event Report: BALLARD CLOSED SUCTION SYSTEM FOR ADULTS, 12 F, T-PIECE; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	2155-5
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for lot m6362t612 was reviewed and the product was produced according to product specifications.A photo of the device was provided by the customer.All information reasonably known as of 20 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
Avanos medical inc.Received a single report that referenced two different incidences, which were associated with separate units.This is the first of two reports.Refer to 8030647-2020-00050 for the second report.It was reported that "the mount is not connecting to the ett [endotracheal tube] with or without flex connector in packet (or similar connector from off the shelf).Not offering a seal causing disruption to ventilation parameters with pressures falling." no ill effects from the closed suction catheter; this was removed and a 14fr [french] used with no issues.
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.A photo of the device was provided by the customer.The photo was reviewed; however, the reported failure could not be confirmed.Root cause could not be determined.All information reasonably known as of 17 sep 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, 12 F, T-PIECE
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 10295808
• Report Number: 8030647-2020-00049
• Device Sequence Number: 16871949
• Product Code: BSY
• UDI-Device Identifier: 00609038982953
• UDI-Public: 00609038982953
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/17/2020

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: 12/28/2021
• Device Model Number: 2155-5
• Device Catalogue Number: UNKNOWN
• Device Lot Number: M6362T612
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 09/17/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1