MAUDE Adverse Event Report: BALLARD MULTI-ACCESS CATHETER FOR NEONATES/PEDIATRICS; VAP MAC-CATH

Model Number	1900
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility medwatch report (b)(4) is attached for reference.A review of the device history record is in-progress.The actual complaint product was not returned for evaluation.All information reasonably known as of 06 may 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.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
Per information provided in fda user facility report (b)(4) received on apr 14, 2021, "halyard multi-access port repeatedly popped off when connected to rusch 2.5mm endotracheal tube (et).Hospital staff report that the multi-access catheter used indicated that it was appropriate for 2.5mm endotracheal tube according to packaging.Patient was reintubated using a different et tube (shiley 2.5mm) and the multi-action catheter did not pop off." "the original intended procedure was administration of medication into the et tube." no further information is available.
Additional Manufacturer Narrative
Corrected data: d1, d2, d4 model and udi.The device history record for lot 30047512 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 01 jun 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.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 MULTI-ACCESS CATHETER FOR NEONATES/PEDIATRICS
• Common Device Name: VAP MAC-CATH
• MDR Report Key: 11787664
• Report Number: 8030647-2021-00013
• Device Sequence Number: 847626
• Product Code: BSY
• UDI-Device Identifier: 10609038101368
• UDI-Public: 10609038101368
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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 Expiration Date: 03/01/2025
• Device Model Number: 1900
• Device Catalogue Number: N/A
• Device Lot Number: 30047512
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• 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: RUSCH ENDOTRACHEAL TUBE
• Patient Age: 1 DA