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

Model Number DYNDH1699

Device Problem Crack (1135)

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

Event Date 01/12/2023

Event Type  No Answer Provided  

Event Description

A cracked specimen vial found in ultrasound biopsy kit.Vial removed, no harm or delay to patient care.

• Brand Name: MEDLINE
• Type of Device: TRAY, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 16351088
• MDR Text Key: 309270942
• Report Number: 16351088
• Device Sequence Number: 1
• Product Code: LRP
• UDI-Device Identifier: 10653160349914
• UDI-Public: (01)10653160349914
• 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: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: DYNDH1699
• Device Catalogue Number: DYNDH1699
• Device Lot Number: 2022092790
• 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: 01/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1