MAUDE Adverse Event Report: MICROTEK MEDICAL INC. MICROTEK; CONTAINER, I.V.

Model Number 1

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2020

Event Type  malfunction  

Event Description

Medi-plast vial decanter from microtek medical, inc.Has issues with the vial decanter cap not staying on the decanter spike while in the package.This problem prevents the aseptic decanting from glass vials.The cap from this particular supply was not covering the spike (ref #2006s, lot #200318).

• Brand Name: MICROTEK
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): MICROTEK MEDICAL INC.; 602 lehmberg road; columbus MS 39702
• MDR Report Key: 10791884
• MDR Text Key: 214801500
• Report Number: 10791884
• Device Sequence Number: 1
• Product Code: KPE
• UDI-Device Identifier: 00748426002511
• UDI-Public: (01)00748426002511
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1
• Device Catalogue Number: 2006S
• Device Lot Number: 200318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1