MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD MAP REPLACEMENT ADULT, 16 FR; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 240165-5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is in-progress.The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 06 aug 2021 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 Description

It was reported that 20 minutes after the patient was changed to a closed circuit, the ventilator alarmed of disconnection.The device was reconnected and disconnected 10 minutes later, "causing desaturation for the patient by default of oxygen supply (the latter is no longer connected to a ventilator).The device is subsequently changed.It appears that one of the plastic connecting rings on which the respirator hose attaches is untimely detaching." additional information has been requested but not yet received.

Manufacturer Narrative

The investigation remains in progress.All information reasonably known as of 03 sep 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.

Manufacturer Narrative

One used sample was returned for evaluation.Examination of the double swivel elbow revealed that the male insert and male lock ring were missing.Examination of the female end of the manifold under uv light revealed no residue of acrylic cement.The complaint is confirmed as reported.The root cause was determined to be potentially manufacturing related.The device history record for lot 30040365 was reviewed and the product was produced according to product specifications.All information reasonably known as of (b)(6) 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 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 REPLACEMENT ADULT, 16 FR
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT S DE RL DE CV; carretera internacional; salida norte no. 1053; magdalena, cp
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 12288823
• MDR Text Key: 265421751
• Report Number: 8030647-2021-00028
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 00609038101132
• UDI-Public: 00609038101132
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2023
• Device Model Number: 240165-5
• Device Catalogue Number: N/A
• Device Lot Number: 30040365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1