MAUDE Adverse Event Report: BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW; VAP CLOSED SUCTION CATHETERS & ACCESSORIES

Model Number	22703-5
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Laceration(s) of Esophagus (2398); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The actual complaint product was not returned for evaluation.Root cause could not be determined.The device history record for lot 30064660 was reviewed and the product was produced according to product specifications.All information reasonably known as of 07 apr 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 complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that the catheter was kinked and after use, "possibly caused some bleeding in the patient." the device was used for two hours before being replaced at 1am on (b)(6) 2021, and the patient improved over the course of the shift and by 8pm on (b)(6) 2021, he "was much better with only minimally blood stained sputum." it was further reported by the nurse that "the patient only had saline nebs and to treat it and i switched him down to a smaller 12fr catheter to help minimize irritation to his airway for the time being.The main treatment was just spotting that the catheter was the problem and removing it." no further information provided.

• Brand Name: BALLARD TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, DOUBLE SWIVEL ELBOW
• Common Device Name: VAP CLOSED SUCTION CATHETERS & ACCESSORIES
• MDR Report Key: 11648079
• Report Number: 8030647-2021-00011
• Device Sequence Number: 3396892
• Product Code: BSY
• UDI-Device Identifier: 00609038989693
• UDI-Public: 00609038989693
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 22703-5
• Device Catalogue Number: N/A
• Device Lot Number: 30064660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2020
• 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: UNKNOWN ENDOTRACHEAL TUBE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR