MAUDE Adverse Event Report: JINHUA KANGDELI MEDICAL APPLIANCES CO.,LTD BOOGIE BABY; TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Model Number	230120
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Boogie baby was found to have a dark/black discoloration on the product when first opening the package.

• Brand Name: BOOGIE BABY
• Common Device Name: TUBE, ASPIRATING, FLEXIBLE, CONNECTING
• Manufacturer (Section D): JINHUA KANGDELI MEDICAL APPLIANCES CO.,LTD
• MDR Report Key: 18131835
• Report Number: MW5148097
• Device Sequence Number: 6468033
• Product Code: BYY
• UDI-Device Identifier: 00814247020697
• UDI-Public: 00814247020697
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/09/2023

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 Model Number: 230120
• Device Lot Number: 2301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown