MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD EM2400 USB SCANNER 4208, SYMB; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 6400-1003

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2016

Event Type  malfunction  

Manufacturer Narrative

The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an exactamix usb scanner cord was frayed and the wire was exposed.The process step when this occurred was not specified.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection identified that the power cable was frayed with the wire exposed.The reported condition was verified.The cause of the reported condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM2400 USB SCANNER 4208, SYMB
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6128896
• MDR Text Key: 60936215
• Report Number: 1416980-2016-17668
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2016

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: Other
• Device Catalogue Number: 6400-1003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1