MAUDE Adverse Event Report: ADVANCE MEDICAL DESIGNS, INC. VIAL DECANTER FOR ASEPTIC TRANSFER OF FLUIDS FROM SMALL VIALS; CONTAINER, I.V.

Model Number 10-106

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

Title: xxxxx.Event desc: the two pieces of the vial decanter separated when they tried to use it.Opened second device - same issue - same lot.What was the original intended procedure? to decant medications from a vial prior to an operating room procedure.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working).

Manufacturer Narrative

All remaining inventory of the used lot in question has been placed in amd's quarantine area to be 100% inspected by amd's quality department.

• Brand Name: VIAL DECANTER FOR ASEPTIC TRANSFER OF FLUIDS FROM SMALL VIALS
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): ADVANCE MEDICAL DESIGNS, INC.; 1241 atlanta industrial dr.; marietta GA 30066
• Manufacturer Contact: david mackie ; 1241 atlanta industrial dr.; marietta, GA 30066 ; 7704223125
• MDR Report Key: 4209969
• MDR Text Key: 5152678
• Report Number: 1037885-2014-00001
• Device Sequence Number: 1
• Product Code: KPE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K852893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 08/01/2014,08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Model Number: 10-106
• Device Catalogue Number: 10-106
• Device Lot Number: 40134C4020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRIOR TO SURGICAL PROCEDURE