MAUDE Adverse Event Report: LEVEL 1

Model Number	L-10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received regarding a level 1 hotline accessory.It was reported that before opening the package, the customer noticed the connector was broken.There was no patient injury.
Additional Manufacturer Narrative
One unit was received along with original packaging.Visual inspection confirmed that the female luer was broken.A digital microscope was used to further inspect the point of breakage and determine if the component was subjected to stress.The breakage was clean.Further molding review was conducted and root cause was determined to be related to a variation in molding.Notifications were sent to appropriate production personnel and suppliers to create awareness for this variation.A dhr was conducted on the provided lot numbers and confirmed that no discrepancies were found during manufacture and appropriate inspections were completed.

• Brand Name: LEVEL 1
• MDR Report Key: 11751179
• Report Number: 3012307300-2021-03630
• Device Sequence Number: 4138219
• Product Code: LGZ
• UDI-Device Identifier: 40695085401002
• UDI-Public: 40695085401002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K911383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

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: 04/09/2023
• Device Model Number: L-10
• Device Catalogue Number: L-10
• Device Lot Number: 3794412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 08/08/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 09/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1