MAUDE Adverse Event Report: AVANOS MEDICAL INC. BALLARD CLOSED SUCTION SYSTEM , ADULTS, 14 FR,DSE; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number 22103

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

H6 health effect - clinical code: bloody secretions/ tracheal trauma.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 12-may-2023 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.

Event Description

It was reported "while caring for a patient with a tracheostomy, 2210 [medical device] was attached instead of the intended 22103 [medical device].[the nurse] states she looked at the ifu [instructions for use] for the 2210 [medical device] and noted that it specifically states not to use on tracheostomy patients, but she noted that it was not on outside packaging.She states that she noted on packaging for 22103 [medical device], it states to use only on tracheostomy patients.Patient developed bloody secretions as a result of being suctioned with 2210 [medical device].A bronchoscopy was done to determine cause for bloody secretions, and that is when it was noted that the closed suction tubing was endotracheal tube length, not tracheostomy length.States that tracheal trauma caused the secretions as a result of the 2210[medical device].They removed the 2210 [medical device] and replaced with 22103 [medical device].".

• Brand Name: BALLARD CLOSED SUCTION SYSTEM , ADULTS, 14 FR,DSE
• 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 84160 ; MX 84160
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 16924497
• MDR Text Key: 315169897
• Report Number: 8030647-2023-00077
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 00609038939070
• UDI-Public: 00609038939070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 22103
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: UNSPECIFIED TRACH TUBE
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 122 KG