MAUDE Adverse Event Report: MEDIMOP MEDICAL PROJECTS LTD. VIAL ADAPTOR; SET, I.V. FLUID TRANSFER

Model Number	8070301
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Within the product bydureon, there is a device called a vial connector that is used to reconstitute the medication.When this was opened for use, the vial connector was damaged.The spike was bent at a 90 degree angle.This has happened before about 6 months ago.Manufacturer response for set, i.V.Fluid transfer, vial adaptor (per site reporter).Product being replaced.

• Brand Name: VIAL ADAPTOR
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): MEDIMOP MEDICAL PROJECTS LTD.; 530 herman o. west drive; exton PA 19341
• MDR Report Key: 7384771
• Report Number: 7384771
• Device Sequence Number: 1292176
• Product Code: LHI
• UDI-Device Identifier: 07290108240160
• UDI-Public: (01)07290108240160
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/28/2018
• Report Date (Section F): 03/28/2018

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: No Information
• Device Expiration Date: 09/01/2020
• Device Model Number: 8070301
• Device Catalogue Number: 8070301
• Device Lot Number: JF0265
• Other Device ID Number: 3754500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Date Report to Manufacturer: 03/28/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO; NO OTHER THERAPIES.
• Date Report Sent to FDA: 03/28/2018