E-Z-HD BARIUM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-26 for E-Z-HD BARIUM manufactured by .

Event Text Entries

[2733284] Three lots of e-z-hd barium were mixed to use for patient care. Instead of being the expected white in color, these product lots were brown. They were not used for patients. Our product was pulled from stock. The manufacturer was notified. Expiration date of the affected lot numbers: 03/2016, lot 68476, lot 68106, lot 67269.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5026315
• MDR Report Key: 2677468
• Date Received: 2012-07-26
• Date of Report: 2012-07-26
• Date Added to Maude: 2012-08-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PHARMACIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: E-Z-HD BARIUM
• Generic Name: BARIUM SULFATE
• Product Code: KTA
• Date Received: 2012-07-26
• Returned To Mfg: 2012-07-25
• Lot Number: 68496
• Device Expiration Date: 2016-03-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Sequence No: 1
• Device Event Key: 0

Device Sequence Number: 2

• Brand Name: E-Z-HD BARIUM
• Generic Name: BARIUM SULFATE
• Product Code: KTA
• Date Received: 2012-07-26
• Returned To Mfg: 2012-07-25
• Lot Number: 68106
• Device Expiration Date: 2016-03-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Sequence No: 2
• Device Event Key: 0

Device Sequence Number: 3

• Brand Name: E-Z-HD BARIUM
• Generic Name: BARIUM SULFATE
• Product Code: KTA
• Date Received: 2012-07-26
• Returned To Mfg: 2012-07-25
• Lot Number: 67269
• Device Expiration Date: 2016-03-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Sequence No: 3
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-07-26