MAUDE Adverse Event Report: ADVANCE MEDICAL DESIGNS, INC. UNBRANDED; CONTAINER, I.V.

Model Number	10-106
Health Effect - Clinical Code	Aseptic loosening (4883)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We just recently purchased this product to use for removing medication from glass vials ¿ it is supposed to be more aseptic than removing the rubber stopper on the medication vial, hopefully helping us reduce risk of infection.The product is difficult to use.It¿s very hard to insert it into the rubber vial stopper ¿ it has a pointy tip, but it¿s very hard to pierce the rubber with it.Also, in the process it cores out pieces of rubber, leaving rubber floating in the medication.

• Brand Name: UNBRANDED
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): ADVANCE MEDICAL DESIGNS, INC.; 1241 atlanta industrial dr; marietta GA 30066
• MDR Report Key: 22122783
• Report Number: 22122783
• Device Sequence Number: 4122574
• Product Code: KPE
• UDI-Device Identifier: 00848340000027
• UDI-Public: (01)00848340000027(10)41219C4528(17)2029-10-31
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025
• Report Date (Section F): 05/21/2025

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: 10-106
• Device Catalogue Number: 10-106
• Device Lot Number: 41219C4528
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/21/2025