MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION CATHETER, ELBOW, NEONATAL/PEDIATRIC; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 208-5

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).All information reasonably known as of 07 jan 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.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 "end tidal co2 monitoring became wet and required changing.Inline suction equipment had become fused to the end tidal monitoring equipment, this resulted in detaching a patient from ventilator and hand ventilating until more equipment could be sourced.Inline suction is not our usual type due to the patient requiring a long than usual suction catheter.Item has been placed in a sealed bag and given to the co-ordinator." additional information received 19-dec-2019 indicated that due to the fusing of the co2 monitoring device, the clinical staff decided to remove the closed suction catheter for a replacement.The patient required manual ventilation until all supplies were obtained.Further additional information has been requested but has not yet been received.

Manufacturer Narrative

Correction: expiration date in d4 was updated.The device history record for lot m19113t501 was reviewed and the product was produced according to product specifications.The investigation remains in process.All information reasonably known as of 03 feb 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.

Manufacturer Narrative

Correction to d4: expiration date and h4: device manufacturer date the actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot m19113t501 was reviewed and the product was produced according to product specifications.All information reasonably known as of 27 feb 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 CATHETER, ELBOW, NEONATAL/PEDIATRIC
• Type of Device: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9563422
• MDR Text Key: 219589449
• Report Number: 8030647-2020-00001
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2024
• Device Model Number: 208-5
• Device Catalogue Number: 109839001
• Device Lot Number: M19113T501
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2020
• Patient Sequence Number: 1