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

Model Number	240148-5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is in-progress.The actual complaint product was not returned for evaluation.Photos of the device were provided by the customer.All information reasonably known as of 25-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 "the incident was caused by the blocking of the green push button which is used to allow the rotation of the dial.As a result of this blockage, the button broke.Therefore, the closed system had to be changed in its entirety.This incident took place in a patient in pressure support." no patient injury was reported.Additional information received 06-nov2020 indicated that apart from changing the closed system, no medical intervention was necessary.The incident was further described as "the kind of green push button that you have to press to allow the wheel to rotate was blocked.Tried to turn it in all sense and take my time, it ended up breaking and i turned the ring into the void.We had to change the entire closed system in a patient using inspiratory support (therefore need to clamp the intubation probe with kocher forceps in a patient with almost no reserve) [physician] was present and accompanied us during the change of material which went well.".
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.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 MAP ADULT, 14 FR, DSY, MDI
• Common Device Name: VAP CLOSED SUCSTION CATHETERS & ACCESSORIES
• MDR Report Key: 10909305
• Report Number: 8030647-2020-00100
• Device Sequence Number: 11570733
• 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?: No
• 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: 11/06/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/26/2020
• 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