MAUDE Adverse Event Report: DELTA®; VALVE, NON-REBREATHING

Model Number	27219-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The proximal end connector of the valve was found to shorter than the distal end connector.The proximal and distal ends measured at 0.187" and 0.226", approximately.The base of the valve on the proximal end of the valve did not appear to be trimmed all the way to the connection of the add on connector and therefore, caused the available connector length on proximal end to be shorter.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that it seemed that the ventricular connection site was much shorter than it was supposed to be.The facility was currently ceasing all use of the valves.Additional information received reported that just by looking at the valve in the sterile packaging, there was a distinct difference between the two connectors.The distal connector was much longer than the proximal connector.

• Brand Name: DELTA®
• Common Device Name: VALVE, NON-REBREATHING
• MDR Report Key: 11243816
• Report Number: 9612501-2021-00186
• Device Sequence Number: 5036061
• Product Code: CBP
• UDI-Device Identifier: 00763000030964
• UDI-Public: 00763000030964
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2025
• Device Model Number: 27219-1
• Device Catalogue Number: 27219-1
• Device Lot Number: 0219927059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 01/28/2021
• Date Device Manufactured: 04/23/2020
• 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: N
• Patient Sequence Number: 1