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

Catalog Number 64001003

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an em2400 usb scanner 4208, symb presented sheathing that was worn through, exposing internal wires.It was not specified with in the process this event occurred.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was returned and an evaluation is complete.A visual inspection was performed and noted scratches on the scanner housing from repeated use with the scanner holder bracket.It was further noted that the power/communication cord outer insulation jacket was frayed, exposing the ground shield braid, and wires.The reported issue of worn through sheathing on scanner cable wires was confirmed.The cause of the condition could not be determined.The device was removed from service.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: 7367656
• MDR Text Key: 103406654
• Report Number: 1416980-2018-01575
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 64001003
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• 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: Reuse
• Patient Sequence Number: 1