MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; GENERAL SURGERY TRAY

Model Number DYNDC2409A

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2022

Event Type  malfunction  

Event Description

Mid 50¿s female with history of adenocarcinoma of the left breast.Procedure: infusion therapy.The protection sheath over the port needle was missing when opened from the packaging.Not used on the patient.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15120910
• MDR Text Key: 296777107
• Report Number: 15120910
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942805693
• UDI-Public: (01)10889942805693(10)2022050990(17)230430
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNDC2409A
• Device Catalogue Number: DYNDC2409A
• Device Lot Number: 2022050990
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/21/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Female
• Patient Weight: 81 KG