MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD MINI-BAL PREP PACK WITH SPECIMEN TRAP; VAP AIRWAY DIAGNOSTICS BAL-CATH

Model Number 140

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 08/22/2019

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 20-sep-2019 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 Description

Avanos medical, inc.Received a single report that referenced seven different incidences, which were associated with separate units, involving seven different events.This is the fourth of seven reports.Refer to 3011270181-2019-00032 for the first event.Refer to 3011270181-2019-00033 for the second event.Refer to 3011270181-2019-00034 for the third event.Refer to 3011270181-2019-00036 for the fifth event.Refer to 3011270181-2019-00037 for the sixth event.Refer to 3011270181-2019-00038 for the seventh event.It was reported that the patient experienced infection after use of the device.Additional information received 11-sep-2019 stated there was no immediate respiratory distress that required intervention related to the product use.

Manufacturer Narrative

All information reasonably known as of 07-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 MINI-BAL PREP PACK WITH SPECIMEN TRAP
• Type of Device: VAP AIRWAY DIAGNOSTICS BAL-CATH
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9098704
• MDR Text Key: 163605511
• Report Number: 3011270181-2019-00035
• Device Sequence Number: 1
• Product Code: MMO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 140
• Device Catalogue Number: 101239301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2020
• Patient Sequence Number: 1
• Treatment: MEDICAL CONVENIENCE KIT; SODIUM CHLORIDE.9
• Patient Outcome(s): Required Intervention