MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC; CONTAINER, LIQUID MEDICATION, GRADUATED

Lot Number G009, Y059, Y052

Device Problem Illegible Information (4050)

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

Event Date 08/08/2020

Event Type  malfunction  

Event Description

Unable to read numbers on medicine cups-markings unclear.Lot# g009, y059, y052.Manufacturer response for medicine cups, (brand not provided) (per site reporter).Medline rep stated that they have not received any other complaints on the medicine cups than from us.

• Type of Device: CONTAINER, LIQUID MEDICATION, GRADUATED
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline pl; mundelein IL 60060
• MDR Report Key: 10566378
• MDR Text Key: 207938575
• Report Number: 10566378
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/28/2020

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
• Device Operator: No Information
• Device Lot Number: G009, Y059, Y052
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1